Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Mullins Transseptal Adult 7F, REF 008551.
Intended for the introduction of cardiovascular catheters into the left side of the heart. Terminated |
DYB | K791963 |
| Jun 27, 2013 | Greatbatch Medical Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14 Terminated |
DYB | K110051 |
| Jun 27, 2013 | Terumo Medical Corporation Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060.
Used to facilitate placing a catheter through the skin into a vein or artery. Terminated |
DYB | K102008 |
| Jun 27, 2013 | Terumo Medical Corporation Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve.
Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human Terminated |
DYB | K091329 |
| Jun 7, 2013 | Endologix Inc Brand Name: AFX" Introducer System, Model Number S17-45.
Lot Numbers: 1079840, 1079843, 1079844, 1079845.
Product Usage:
The AFX Introducer System is intended for use to facilitate the introduction o Terminated |
DYB | K120212 |
| Mar 6, 2013 | Bard Access Systems Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630).
Product Usage: Hickman and Leonard Catheters are des Terminated |
DYB | K830233 |
| Mar 6, 2013 | Bard Access Systems Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600).
Product Usage: H Terminated |
DYB | K830233 |
| Dec 28, 2012 | St Jude Medical Inc Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343
Indicated for introducing various cardiovas Terminated |
DYB | K964518 |
| Dec 22, 2012 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou Terminated |
DYB | K101784 |
| Oct 24, 2012 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou Terminated |
DYB | K101784 |
| Jan 11, 2012 | Thomas Medical Products Inc SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-0 Terminated |
DYB | K003731 |
| Oct 13, 2011 | Angiodynamics, INC 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF;
AngioDynamics, INC.
The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and Terminated |
DYB | K062414 |
| Oct 13, 2011 | Angiodynamics, INC 8F Safe Sheath Introducer, Catalog number: V18;
AngioDynamics, INC.
The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure. Terminated |
DYB | K073100 |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812
Guiding Sheath is used to facilitate the introduction of interven Terminated |
DYB | K012812 |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854
Guiding Sheath is used to facilitate the introduction of interventional and diagno Terminated |
DYB | K012854 |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185
Guiding Sheath is used to facilitate the introduction of interventional and dia Terminated |
DYB | K052185 |
| Mar 25, 2011 | Arrow International Inc Percutaneous Sheath Introducer Kit
Intended usage: Permits venous access and catheter introduction to the central circulation system Terminated |
DYB | K780532 |
| Feb 14, 2011 | Thomas Medical Products Inc Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catal Terminated |
DYB | K003731 |
| Feb 14, 2011 | Thomas Medical Products Inc Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507M Terminated |
DYB | K934901 |
| Feb 4, 2011 | Arstasis, Inc Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft
and (3) Handle with control Terminated |
DYB | K091006 K100615 +1 |
| Jan 28, 2011 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah.
Intended to provide access and facilitate the percutaneous introduction of variou Terminated |
DYB | K082063 |
| Jan 21, 2011 | Arrow International Inc Super Arrow-Flex(R) PSI Set
Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and Terminated |
DYB | K780532 |
| Sep 25, 2010 | Arrow International Inc MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters Terminated |
DYB | K002507 |
| Aug 27, 2010 | Greatbatch Medical Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Med Terminated |
DYB | K093232 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093. Terminated |
DYB | K091137 K092575 +1 |
| 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 |
| Mar 10, 2010 | Baylis Medical Corp * Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator Terminated |
DYB | K013919 |
| Mar 5, 2010 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The p Terminated |
DYB | K940079 |
| Mar 5, 2010 | Arrow International Inc MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters Terminated |
DYB | K011761 |
| Mar 4, 2010 | Thomas Medical Products Inc Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton.
Intended to allow left heart catheterizati Terminated |
DYB | K040713 |
| Feb 2, 2010 | Thomas Medical Products Inc Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and Terminated |
DYB | K003731 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introducti Terminated |
DYB | K082063 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction o Terminated |
DYB | K082063 |
| Nov 24, 2009 | Thomas Medical Products Inc Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. Terminated |
DYB | K083269 |
| 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 |
| Aug 25, 2009 | Edwards Lifesciences, Llc Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only.
Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion. Terminated |
DYB | K981909 |
| Jun 24, 2009 | Arrow International Inc Arrow Two-Lumen Central Venous Access (MAC) Terminated |
DYB | K002507 |
| Jun 24, 2009 | Arrow International Inc Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers Terminated |
DYB | K940079 |
| Jun 24, 2009 | Arrow International Inc Arrow Super Arrow-Flex Percutaneous Sheath Introducers Terminated |
DYB | K924607 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facili Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM, REF No.: PSS-8F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.018" X 40CM NT/PT Guide Wire; REF No.: PSS-8F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facili Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire; REF No.: PSS-7F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-7F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840 Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facilit Terminated |
DYB | K082063 |
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