Company ยท US
Ev3, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2014. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
91recalls (0 in 12 months)
86recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 83 |
| MCW | Catheter, Peripheral, Atherectomy | 11 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 10 |
| DQY | Catheter, Percutaneous | 7 |
| DQX | Wire, Guide, Catheter | 3 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 3 |
| NIP | Stent, Superficial Femoral Artery | 3 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 3 |
| DXE | Catheter, Embolectomy | 2 |
| KRA | Catheter, Continuous Flush | 2 |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 |
| NIM | Stent, Carotid | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 2014 | K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER Ev3, Inc. | LIT |
| Sep 26, 2013 | K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER Ev3, Inc. | LIT |
| May 24, 2013 | K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER Ev3, Inc. | LIT |
| Feb 12, 2013 | K123544 | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER Ev3, Inc. | LIT |
| Oct 27, 2011 | K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc. | MCW |
| Oct 27, 2011 | K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NTE |
| Sep 16, 2011 | K111490 | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS Ev3, Inc. | KRA |
| Apr 14, 2011 | K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER Ev3, Inc. | LIT |
| Jan 5, 2011 | K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc. | MCW |
| Dec 6, 2010 | K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER Ev3, Inc. | LIT |
| Feb 2, 2010 | K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL Ev3, Inc. | MJN |
| Dec 9, 2009 | K093750 | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA Ev3, Inc. | KRA |
| Nov 13, 2009 | K093286 | POWERCROSS .018 OTW PTA DILATION CATHETER Ev3, Inc. | LIT |
| Nov 6, 2009 | K093301 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc. | MCW |
| Aug 7, 2009 | K092299 | TRAILBLAZER SUPPORT CATHETER Ev3, Inc. | DQY |
| May 1, 2009 | K090849 | MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 Ev3, Inc. | DQY |
| Apr 16, 2009 | K090728 | HYPERGLIDE OCCLUSION BALLOON SYSTEM Ev3, Inc. | MJN |
| Dec 4, 2008 | K082854 | NANOCORSS .014 OTW PTA DILATATION CATHETER Ev3, Inc. | DQY |
| Nov 20, 2008 | K082579 | EVERCROSS .035 OTW PTA DILATATION CATHETER Ev3, Inc. | DQY |
| Mar 18, 2008 | K072301 | 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 Ev3, Inc. | FGE |
| Jan 19, 2007 | K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NFA |
| Nov 14, 2006 | K063204 | SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NTE |
| Aug 31, 2006 | K061566 | PRIMUS GPS BILIARY STENT SYSTEM Ev3, Inc. | FGE |
| Aug 11, 2006 | K062201 | SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NFA |
| Jun 23, 2006 | K053195 | SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NFA |
| Mar 8, 2006 | K060057 | PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM Ev3, Inc. | FGE |
| Feb 17, 2006 | K052659 | SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NTE |
| Jun 17, 2005 | K051379 | PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT Ev3 Corporation | FGE |
| Apr 20, 2005 | K050725 | PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3 Corporation | FGE |
| Dec 9, 2004 | K043243 | PRIMUS STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Sep 8, 2004 | K021096 | X-SIZER CATHETER SYSTEM Ev3 Corporation | MCW |
| Aug 23, 2004 | K042204 | MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3, Inc. | FGE |
| Apr 28, 2004 | K040653 | PARAMOUNT MINI GPS BILIARY STENT SYSTEM Ev3, Inc. | FGE |
| Mar 2, 2004 | K040345 | MODIFICATION TO NITREX NITINOL GUIDEWIRE Ev3, Inc. | DQX |
| Nov 21, 2003 | K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Nov 17, 2003 | K033134 | MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Oct 22, 2003 | K032580 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Aug 8, 2003 | K032206 | PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION Ev3, Inc. | FGE |
| Jun 24, 2003 | K031864 | NITREX NITINOL GUIDEWIRE Ev3 Corporation | DQX |
| Jan 24, 2003 | K024021 | NITREX NITINOL GUIDEWIRE Ev3 Corporation | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2025 | ev3 Inc Medtronic NanoCross Elite PTA catheter,
REF numbers amd sizes:
1) AB14W050020090, Size: 5MM X 20MM X 90CM;
2) AB14W050020150, Size: 5MM X 20MM X 150CM;
3) AB14W050040090, Size: 5MM X 40MM X Open, Classified |
LIT | K141118 |
| Mar 7, 2022 | ev3 Inc. Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. Terminated |
MCW | K212027 |
| Mar 7, 2022 | ev3 Inc. Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature. Terminated |
MCW | K212027 |
| Jan 19, 2022 | ev3 Inc. Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire.
The HawkOne directional ather Terminated |
MCW | K161361 |
| Jan 19, 2022 | ev3 Inc. Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire.
The HawkOne directional ath Terminated |
MCW | K161361 |
| Aug 26, 2020 | ev3 Inc. Pacific Xtreme (PTCA Balloon Dilation Catheter) Terminated |
LIT | K103464 |
| May 23, 2016 | Ev3, Inc. EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080.
The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Niti Terminated |
NIP | None listed |
| Apr 22, 2016 | ev3, Inc. ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. Terminated |
LIT | K093286 |
| Dec 29, 2014 | Ev3, Inc. ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only.
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require perc Terminated |
NIM | None listed |
| Dec 29, 2014 | Ev3, Inc. ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only.
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require pe Terminated |
NIM | None listed |
| Apr 23, 2014 | Ev3, Inc. ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Periphera Terminated |
DQY | K082579 K103322 |
| Dec 23, 2010 | Ev3, Inc. ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030 Terminated |
DQY | K082854 K090849 |
| Dec 16, 2010 | Ev3, Inc. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only.
ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " Terminated |
FGE | K050725 |
| May 13, 2010 | Ev3, Inc. ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Terminated |
FGE | K060057 |
| Mar 18, 2010 | Ev3, Inc. SilverHawk Peripheral Cutter Driver Plaque Excision System
REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at Terminated |
MCW | K061188 |
| Dec 23, 2009 | Ev3, Inc. TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO.
US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135,
SC-014-150, SC-018-150, Terminated |
DQY | K092299 |
| Dec 1, 2009 | Ev3, Inc. Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx onl Terminated |
FGE | K060057 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120.
In the US, the intended as a palliative treatment of malignant neoplasms i Terminated |
FGE | K033314 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120.
In the US, the intended as a palliative treatment of malignant neoplasms Terminated |
FGE | K033314 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120.
In the US, the intended as a palliative treatment of malignant neoplasms in th Terminated |
FGE | K033314 |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120.
In the US, the intended as a palliative treatment of malignant neoplasms in th Terminated |
FGE | K033314 |
| Sep 26, 2008 | Ev3, Inc ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.
Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-1 Terminated |
FGE | K061566 |
| Sep 26, 2008 | Ev3, Inc ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System.
Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35 Terminated |
FGE | K061566 |
| Sep 21, 2008 | Ev3, Inc ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07. Terminated |
NIP | None listed |
| Sep 11, 2008 | Ev3, Inc ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which ballo Terminated |
NIP | None listed |
| Aug 26, 2008 | Ev3, Inc Ev3 Primus GPS Biliary Stent System
8 mm, 37 mm, B7, .40 mm, 5Fr,
REF BXB35-08-37-75
Use before 2009-02
Sterile EO
Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920
Intended as a palliative treatm Terminated |
FGE | K043243 |
| Aug 26, 2008 | Ev3, Inc Ev3 Protege GPS Biliary Stent Systems
6 mm, 60 mm, 120cm, .35, 6Fr, OTW
Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920
REF SERB65-06-60-120
Lot 2675311
Use before 2009-01-01
Sterile EO
Intended Terminated |
FGE | K032580 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-002.
ev3 IntraStent LD Max Large Diameter Periphera Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-001.
ev3 IntraStent LD Max Large Diameter Periphera Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000.
ev3 IntraStent LD Max Large Diameter Peripher Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-002.
ev3 IntraStent LD Mega Large Diameter Periph Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-001.
ev3 IntraStent LD Mega Large Diameter Perip Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-000
ev3 IntraStent LD Mega Large Diameter Peri Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36,
ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002.
ev3 IntraStent LD DoubleStrut La Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD DoubleStrut
Large Diameter Biliary Stent, Model Number: S15-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000.
ev3 IntraStent LD DoubleStrut
Large Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002.
ev3 IntraStent DoubleStrut Peripheral Stent, Model Num Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001. Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000. Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent Biliary Stent, Model Number: S10-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0648-001. Terminated |
FGE | K980290 |
| Jul 11, 2007 | Ev3, Inc Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO
ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA
THE ENDOVASCULAR COMPANY.
The Snare Kit contains Terminated |
DXE | K972511 |
| Feb 1, 2007 | Ev3, Inc ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. Terminated |
FGE | K033314 |
| Jun 14, 2006 | Ev3, Inc X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3 Terminated |
MCW | K021096 |
| Jun 14, 2006 | Ev3, Inc X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3 Terminated |
MCW | K021096 |
| Jun 2, 2006 | Ev3, Inc Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Min Terminated |
DXE | K901502 |
| May 31, 2006 | Ev3, Inc ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compl Terminated |
FGE | K043243 |
| May 3, 2006 | Ev3, Inc IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expanda Terminated |
FGE | K993904 |
| Mar 18, 2006 | Ev3, Inc ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of Terminated |
FGE | K011806 |
| Jan 25, 2006 | Ev3, Inc Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75 Terminated |
FGE | K043243 |
| Jun 25, 2005 | Ev3 ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-10-30-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. Terminated |
FGE | K033314 |
| Jun 25, 2005 | Ev3 ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. Terminated |
FGE | K033314 |
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