Company ยท US
Cordis Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2022. Name variants (Inc, Corp, punctuation) are merged.
328510(k) clearances (0 in 12 months)
146recalls (0 in 12 months)
49recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 83 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 52 |
| DQO | Catheter, Intravascular, Diagnostic | 37 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 36 |
| DQX | Wire, Guide, Catheter | 26 |
| DQY | Catheter, Percutaneous | 26 |
| DYB | Introducer, Catheter | 25 |
| DXY | Implantable Pacemaker Pulse-Generator | 21 |
| JXG | Shunt, Central Nervous System And Components | 18 |
| DTB | Permanent Pacemaker Electrode | 13 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 8 |
| DTK | Filter, Intravascular, Cardiovascular | 7 |
| DWZ | Device, Biopsy, Endomyocardial | 5 |
| LDF | Electrode, Pacemaker, Temporary | 5 |
| DXQ | Blood Pressure Cuff | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 3 |
| DTD | Pacemaker Lead Adaptor | 3 |
| GWM | Device, Monitoring, Intracranial Pressure | 3 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2022 | K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire Cordis Corporation | NTE |
| Feb 17, 2022 | K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands Cordis Corporation | DQO |
| Apr 23, 2021 | K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter Cordis Corporation | LIT |
| Feb 26, 2021 | K202167 | Brite Tip Radianz Guiding Sheath Cordis Corporation | DYB |
| Oct 9, 2020 | K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter Cordis Corporation | LIT |
| Sep 11, 2020 | K201333 | SABER .035 PTA Dilatation Catheter Cordis Corporation | LIT |
| Aug 15, 2018 | K181592 | RAIN Sheath Transradial Cordis Corporation | DYB |
| Apr 18, 2018 | K180081 | RAILWAY Sheathless Access System Cordis Corporation | DYB |
| Jan 14, 2015 | K143412 | ADROIT Guiding Catheter Cordis Corporation | DQY |
| Jun 27, 2014 | K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER Cordis Corporation | LIT |
| Mar 12, 2014 | K130981 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM Cordis Corp. | FGE |
| Jun 14, 2012 | K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corporation | LIT |
| May 4, 2012 | K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corp. | LIT |
| Jul 9, 2010 | K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE Cordis Corp. | NTE |
| Aug 25, 2008 | K082143 | MICRO GUIDE CATHETER XP Cordis Corp. | PDU |
| Feb 6, 2008 | K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB Cordis Corp. | FGE |
| Apr 27, 2006 | K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX Cordis Corp. | FGE |
| Apr 1, 2005 | K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER Cordis Corp. | LIT |
| Dec 17, 2004 | K040592 | CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE Cordis Corp. | DQX |
| Nov 8, 2004 | K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Aug 3, 2004 | K041796 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corporation | FGE |
| Mar 22, 2004 | K034050 | CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F Cordis Corporation | DTK |
| Dec 22, 2003 | K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM Cordis Corp. | FGE |
| Sep 17, 2003 | K032137 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Sep 4, 2003 | K032457 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Jul 7, 2003 | K031777 | MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Jun 16, 2003 | K031197 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Mar 10, 2003 | K030409 | SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM Cordis Corp. | FGE |
| Dec 18, 2002 | K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER Cordis Corp. | KNQ |
| Oct 25, 2002 | K023217 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Oct 18, 2002 | K023116 | CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B Cordis Corp. | DTK |
| Aug 14, 2002 | K021898 | SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Jun 28, 2002 | K021345 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM Cordis Corp. | FGE |
| Jun 13, 2002 | K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP Cordis Corp. | DQY |
| Apr 12, 2002 | K020809 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT Cordis Corp. | FGE |
| Mar 20, 2002 | K020316 | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU Cordis Corp. | DQO |
| Feb 11, 2002 | K020052 | SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Oct 5, 2001 | K012993 | MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Sep 7, 2001 | K012590 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM Cordis Corp. | FGE |
| Aug 27, 2001 | K010411 | PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM Cordis Corp. | FGE |
| Aug 1, 2001 | K012087 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT Cordis Corp. | FGE |
| Jun 15, 2001 | K003920 | CORDIS M3 PTA DILATATION CATHETER Cordis Corp. | DQY |
| Jun 6, 2001 | K010083 | TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A Cordis Corp. | DTK |
| Mar 16, 2001 | K010445 | PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM Cordis Corp. | FGE |
| Jan 19, 2001 | K003964 | TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B Cordis Corp. | DTK |
| Nov 22, 2000 | K003365 | S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) Cordis Corp. | FGE |
| Nov 22, 2000 | K003336 | MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Oct 30, 2000 | K003159 | CORDIS SLALOM PTA BALLOON CATHETER Cordis Corp. | LIT |
| Jul 18, 2000 | K001843 | S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Jul 7, 2000 | K000062 | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT Cordis Corp. | DTK |
Newest 50 of 328.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2021 | Cordis Corporation SMART FLEX 10x100 BIL, 120cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Open, Classified |
FGE | K121125 |
| Oct 1, 2021 | Cordis Corporation SMART FLEX 10x100 BIL, 80cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Open, Classified |
FGE | K121125 |
| Oct 1, 2021 | Cordis Corporation SMART FLEX 8x60 BIL, 80cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Open, Classified |
FGE | K121125 |
| Oct 1, 2021 | Cordis Corporation SMART FLEX 6x150 BIL, 120cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Open, Classified |
FGE | K121125 |
| Oct 1, 2021 | Cordis Corporation SMART FLEX 6x120 BIL, 120cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Open, Classified |
FGE | K121125 |
| Oct 1, 2021 | Cordis Corporation SMART FLEX 9x60 BIL, 80cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Open, Classified |
FGE | K121125 |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB Terminated |
DQO | K992347 |
| Sep 15, 2021 | Cordis Corporation Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB Terminated |
DQO | K992347 |
| Jul 19, 2021 | Cordis Corporation Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X Terminated |
LIT | K133843 |
| Jun 9, 2021 | Cordis Corporation Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Terminated |
DRE | K970392 |
| Feb 11, 2021 | Cordis Corporation PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920R Completed |
NIM | None listed |
| Feb 28, 2020 | Cordis Corporation Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S Terminated |
LIT | K032737 |
| Oct 4, 2019 | Cordis Corporation Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. Terminated |
LIT | K991811 |
| Feb 7, 2019 | Cordis Corporation Cordis Vista Brite Tip & Androit Guiding Catheters
Product Usage:
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or per Terminated |
DQY | K021593 K143412 +3 |
| Sep 5, 2018 | Cordis Corporation Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obs Terminated |
LIT | K121442 |
| Nov 15, 2017 | Cordis Corporation Cordis S.M.A.R.T. Flex Biliary Stent System
Product Usage:
Is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | K121125 |
| Feb 16, 2017 | Cordis Corporation Cordis S.M.A.R.T. Flex Vascular Stent System Terminated |
MAF | None listed |
| May 4, 2016 | Cordis Corporation Cordis PRECISE (R) RX Nitinol Stent System (Biliary) Terminated |
NIM | None listed |
| May 4, 2016 | Cordis Corporation Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) Terminated |
NIM | None listed |
| Mar 15, 2016 | Cordis Corporation CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM
The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intra Terminated |
DRE | K970392 |
| Aug 18, 2015 | Cordis Corporation RenLane Renal Denervation Catheter; Cat No.: D135601.
Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure. Terminated |
MPB | None listed |
| Jan 16, 2015 | Cordis Corporation Cordis POWERFLEX PRO PTA Dilatation Catheter
Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of Terminated |
LIT | K121442 |
| Aug 28, 2014 | Cordis Corporation Cordis EMPIRA RX PTCA Dilatation Catheter Terminated |
LOX | K110133 |
| Aug 28, 2014 | Cordis Corporation Cordis EMPIRA NC RX PTCA Dilatation Catheter Terminated |
LOX | K110133 |
| Jun 11, 2014 | Cordis Corporation Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. Terminated |
LOX | K110133 |
| Oct 25, 2013 | Cordis Corporation Cordis OPTEASE Vena Cava Filter
Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromb Terminated |
DTK | K091077 |
| Oct 1, 2013 | Cordis Corporation Cordis ADROIT 6F Guiding Catheter
Product Usage:
For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. Terminated |
DQY | K131225 |
| Aug 7, 2013 | Cordis Corporation Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Terminated |
DTK | K034050 K091077 |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial Terminated |
NIP | None listed |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial Terminated |
NIP | None listed |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | K112522 |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial Terminated |
NIP | None listed |
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | K081996 |
| Jan 25, 2013 | Cordis Corporation Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambu Terminated |
MGB | None listed |
| Sep 21, 2012 | Cordis Corporation Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnso Terminated |
LOX | None listed |
| Sep 21, 2012 | Cordis Corporation Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201 Terminated |
LOX | None listed |
| May 10, 2012 | Cordis Corporation Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assemble Terminated |
FGE | K031777 K042969 +1 |
| May 10, 2012 | Cordis Corporation Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico Terminated |
FGE | K031777 K042969 +1 |
| Feb 15, 2012 | Cordis Corporation S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disea Terminated |
NIO | None listed |
| Feb 15, 2012 | Cordis Corporation S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree.
Model numbers are Cxx Terminated |
FGE | K031777 |
| Nov 17, 2011 | Cordis Corporation SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sidehole Terminated |
DQO | K992347 |
| Nov 17, 2011 | Cordis Corporation SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter** Terminated |
DQO | K992347 |
| Apr 20, 2010 | Cordis Corporation Cordis, AVANTI+ Introducer, STERILE EO, For one use only.
Catalog 402656X Lot # 15076369.
Catalog 504606X Lot # 15075717.
Catalog 504656X Lot # 15076362, 15076363, 15076364. Terminated |
DYB | K945616 |
| Jan 13, 2010 | Cordis Corporation Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile.
Contents 5 Hydrophilic guidewires and to Terminated |
DQX | K011905 |
| Nov 5, 2009 | Cordis Corporation Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA.
Distributed by Cordis Corporation, 14201 North West 60th Avenue, Terminated |
DYB | K083269 |
| Dec 30, 2008 | Cordis Corporation MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular
Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurov Terminated |
KRA | K983003 |
| Oct 31, 2008 | Cordis Corporation Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The can Terminated |
MCW | K001577 K014117 +3 |
Newest 50 of 146.