Ev3 Inc

FDA Filings

This page includes the latest FDA filings for Ev3 Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2183870
FEI Number2183870
Nameev3, Inc
Owner & OperatorMedtronic, Inc.
Contact Address710 Medtronic Parkway
Minneapolis MN 55432 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4600 NATHAN LN. NORTH
Plymouth, MN 55442 US
Establishment Type
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
EV3, INC
Kendall™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
Wholey™ 2024-06-10
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
AMPLATZ GOOSE NECK™ 2021-07-08
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
Chocolate® 2021-06-25
EV3, INC
AMPLATZ GOOSE NECK™ 2020-10-26
EV3, INC
AMPLATZ GOOSE NECK™ 2020-10-26
EV3, INC
AMPLATZ GOOSE NECK™ 2020-10-26
EV3, INC
AMPLATZ GOOSE NECK™ 2020-10-26
EV3, INC
AMPLATZ GOOSE NECK™ 2020-10-26
EV3, INC
AMPLATZ GOOSE NECK™ 2020-10-26
EV3, INC
Babywire™ 2020-08-24
EV3, INC
Babywire™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
NITREX™ 2020-08-24
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
EV3, INC
Chocolate® 2020-06-23
ev3, Inc [Medtronic, Inc.]
EverCross2019-04-26
ev3, Inc [Medtronic, Inc.]
EverCross .035? OTW PTA Dilatation Catheter2019-04-26
ev3, Inc [Medtronic, Inc.]
EverCross2019-04-26
ev3, Inc [Medtronic, Inc.]
EverCross .035? OTW PTA Dilatation Catheter2019-04-26
ev3, Inc [Medtronic, Inc.]
Chocolate PTA Balloon Catheter2018-03-27
ev3, Inc [Medtronic, Inc.]
VenaSeal Closure System2017-10-31
ev3, Inc [Medtronic, Inc.]
TurboHawk Peripheral Plaque Excision System2017-06-21
ev3, Inc [Medtronic, Inc.]
SilverHawk Peripheral Plaque Excision System2017-06-21
ev3, Inc [Medtronic, Inc.]
HawkOne? Directional Atherectomy System Intraluminal artery stripper2016-10-14
ev3, Inc [Medtronic, Inc.]
HawkOne Directional Atherectomy System2016-10-14
ev3, Inc [Medtronic, Inc.]
HawkOne 6Fr2016-10-14
ev3, Inc [Medtronic, Inc.]
TrailBlazer Angled Support Catheter2016-10-05
ev3, Inc [Medtronic, Inc.]
SpiderFX Embolic Protection Device2016-09-06
ev3, Inc [Medtronic, Inc.]
NanoCross Elite 0.014 Over-the-Wire PTA Balloon Dilatation Catheter2016-03-18
ev3, Inc [Medtronic, Inc.]
The Sheath2015-11-18
ev3, Inc [Medtronic, Inc.]
Protege GPS Self-Expanding Stent System2015-09-02
ev3, Inc [Medtronic, Inc.]
Protege GPS 6Fr 6-9mm .035 Biliary2015-09-02
ev3, Inc [Medtronic, Inc.]
Fortrex2014-11-13
ev3, Inc [Medtronic, Inc.]
Fortrex 0.035? OTW PTA Balloon Catheter2014-11-13
ev3, Inc [Medtronic, Inc.]
HawkOne Directional Atherectomy System2014-11-13
ev3, Inc [Medtronic, Inc.]
HawkOne 7Fr2014-11-13
ev3, Inc [Medtronic, Inc.]
SilverHawk Peripheral Plaque Excision System2014-11-13
ev3, Inc [Medtronic, Inc.]
SilverHawk Peripheral Plaque Excision System2014-11-13
ev3, Inc [Medtronic, Inc.]
ClosureFAST?2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureFAST? Radiofrequency Catheter2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureFAST? Catheters2014-08-18
ev3, Inc [Medtronic, Inc.]
VNUS? ClosureFAST?2014-08-18
ev3, Inc [Medtronic, Inc.]
VNUS? ClosureFAST? catheter2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureFAST?2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureFAST? Radiofrequency Catheter 3cm2014-08-18
ev3, Inc [Medtronic, Inc.]
CF7-7-60- ClosureFast Endovenous Radiofrequeney Ablation (RFA) Catheter 7.0 cm Heating Segment, 60 cm Catheter Length 72014-08-18
ev3, Inc [Medtronic, Inc.]
CF7-7-100- ClosureFast Endovenous Radiofrequeney Ablation (RFA) Catheter 7.0 cm Heating Segment, 100 cm Catheter Length2014-08-18
ev3, Inc [Medtronic, Inc.]
CF7-3-60- ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter 3.0 cm Heating Element Segment, 60 cm Catheter L2014-08-18
ev3, Inc [Medtronic, Inc.]
VNUS RFSFlex2014-08-18
ev3, Inc [Medtronic, Inc.]
VNUS RFS2014-08-18
ev3, Inc [Medtronic, Inc.]
RFSFlex2014-08-18
ev3, Inc [Medtronic, Inc.]
RFS Stylet2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureRFS Endovenous Radiofrequency Stylet2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureRFS Endovenous Radiofrequency Stylet 6 Fr/Ch (2.0 mm) x 12 em2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureFAST Stylet2014-08-18
ev3, Inc [Medtronic, Inc.]
VNUS Radiofrequency Generator, Model RFG22014-08-18
ev3, Inc [Medtronic, Inc.]
RFG22014-08-18
ev3, Inc [Medtronic, Inc.]
RFG2 Next Gen2014-08-18
ev3, Inc [Medtronic, Inc.]
ClosureRFG Radiofrequency Generator (RFG2)2014-08-18
ev3, Inc [Medtronic, Inc.]
RFG32014-08-11
ev3, Inc [Medtronic, Inc.]
ClosureRFG2014-08-11
ev3, Inc [Medtronic, Inc.]
ClosureRFG Radiofrequency Generator2014-08-11
ev3, Inc [Medtronic, Inc.]
ClosureRFG Generator2014-08-11
EV3 INC
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER2014-07-18
ev3, Inc [Medtronic, Inc.]
NanoCross Elite .014? Over The Wire PTA Balloon Dilatation Catheter2013-12-10
ev3, Inc [Medtronic, Inc.]
RapidCross PTA Rapid Exchange Balloon Dilatation Catheter2013-12-10
EV3 INC
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER2013-09-26
ev3, Inc [Medtronic, Inc.]
Protege EverFlex Self-Expanding Biliary Stent System2013-06-17
ev3, Inc [Medtronic, Inc.]
Protege GPS 6Fr 10mm .035 .0182013-05-29
EV3 INC.
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER2013-05-24
ev3, Inc [Medtronic, Inc.]
IntraStent LD DoubleStrut Biliary Stent2013-03-07
ev3, Inc [Medtronic, Inc.]
IntraStent DoubleStrut Biliary Stent2013-03-07
ev3, Inc [Medtronic, Inc.]
Amplatz Goose Neck Microsnare2013-03-07
ev3, Inc [Medtronic, Inc.]
RapidCross PTA Rapid Exchange Balloon Dilatation Catheter2013-03-07
ev3, Inc [Medtronic, Inc.]
RapidCross PTA Rapid Exchange Balloon Dilatation Catheter2013-03-07
ev3, Inc [Medtronic, Inc.]
AqWire Hydrophilic Guidewire2013-03-07
EV3 INC
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER2013-02-12
ev3, Inc [Medtronic, Inc.]
Nitrex Nitinol Guidewire2013-01-24
ev3, Inc [Medtronic, Inc.]
Mantaray? Guidewires2012-11-28
ev3, Inc [Medtronic, Inc.]
Enteer Guidewire2012-11-28
ev3, Inc [Medtronic, Inc.]
BridgePoint Medical Peripheral System: Mantaray? Guidewires2012-11-28
ev3, Inc [Medtronic, Inc.]
Enteer (Mantaray) Guidewire M-600,M6001,M6002,M-6003,M-6004,M-60052012-11-28
ev3, Inc [Medtronic, Inc.]
Mantaray Guidewire2012-11-28
ev3, Inc [Medtronic, Inc.]
Enteer? Guidewire2012-11-28
ev3, Inc [Medtronic, Inc.]
Peripheral System Percutaneous Catheter2012-11-21
ev3, Inc [Medtronic, Inc.]
Mantaray Guidewires2012-11-21
ev3, Inc [Medtronic, Inc.]
Mantaray Catheters2012-11-21
ev3, Inc [Medtronic, Inc.]
Enteer Re-entry Catheter, Enteer GuideWire, Viance Crossing Catheter2012-11-21
ev3, Inc [Medtronic, Inc.]
BigBoss Catheters2012-11-21
ev3, Inc [Medtronic, Inc.]
Enteer (Mantaray) Percutaneous Catheter M-4000 and M-40012012-11-21
ev3, Inc [Medtronic, Inc.]
Viance2012-11-21
ev3, Inc [Medtronic, Inc.]
Viance Percutaneous Catheter2012-11-21
ev3, Inc [Medtronic, Inc.]
BigBoss Catheter2012-11-21
ev3, Inc [Medtronic, Inc.]
Enteer (Mantaray) Percutaneous Catheter M-4000 and M-40012012-11-21
ev3, Inc [Medtronic, Inc.]
Everflex Self-Expanding Peripheral Stent With Entrust Delivery System2012-04-30
ev3, Inc [Medtronic, Inc.]
EverFlex Self-Expanding Peripheral Stent System2012-04-30
ev3, Inc [Medtronic, Inc.]
Wholey Wire2012-04-30
ev3, Inc [Medtronic, Inc.]
Wholey Guide Wire System2012-04-30
ev3, Inc [Medtronic, Inc.]
models THS-LS-C, THS-LX-C2012-01-04
ev3, Inc [Medtronic, Inc.]
TurboHawk Peripheral Plaque Excision System2012-01-04
ev3, Inc [Medtronic, Inc.]
SpiderFX Embolic Protection Device2011-11-02
ev3, Inc [Medtronic, Inc.]
Peripheral Indication2011-11-02
EV3 INC
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM2011-10-27
EV3 INC
SPIDERFX EMBOLIC PROTECTION DEVICE2011-10-27
EV3 INC
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS2011-09-16
ev3, Inc [Medtronic, Inc.]
EverCross .035? OTW PTA Dilatation Catheter - Refresh2011-04-29
ev3, Inc [Medtronic, Inc.]
EverCross .035? OTW PTA Dilatation Catheter - Refresh2011-04-29
EV3 INC
EVERCROSS 0.035 OTW PTA DILATATION CATHETER2011-04-14
ev3, Inc [Medtronic, Inc.]
models SS-C, SS-CL, SX-C2011-01-17
ev3, Inc [Medtronic, Inc.]
TurboHawk Peripheral Plaque Excision System2011-01-17
EV3 INC
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM2011-01-05
ev3, Inc [Medtronic, Inc.]
EverCross Refresh2010-12-21
ev3, Inc [Medtronic, Inc.]
EverCross .035" Over The Wire PTA Dilatation Catheter2010-12-21
ev3, Inc [Medtronic, Inc.]
EverCross .035" OTW PTA Dilatation Catheter2010-12-21
EV3 INC
EVERCROSS 0.035 OTW PTA DILATION CATHETER2010-12-06
ev3, Inc [Medtronic, Inc.]
The Big Easy Y-Adapter2010-08-25
EV3 INC
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL2010-02-02
EV3 INC
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA2009-12-09
ev3, Inc [Medtronic, Inc.]
TurboHawk Supper Cutter LS-E, LX-E2009-12-03
ev3, Inc [Medtronic, Inc.]
PowerCross .018 OTW Balloon2009-12-03
ev3, Inc [Medtronic, Inc.]
PowerCross .018 OTW Balloon2009-12-03
EV3 INC
POWERCROSS .018 OTW PTA DILATION CATHETER2009-11-13
EV3 INC
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM2009-11-06
ev3, Inc [Medtronic, Inc.]
TrailBlazer Support Catheter2009-09-02
EV3 INC
TRAILBLAZER SUPPORT CATHETER2009-08-07
ev3, Inc [Medtronic, Inc.]
NanoCross .014" OTW PTA2009-05-13
ev3, Inc [Medtronic, Inc.]
.210 mm Product Expansion2009-05-13
EV3 INC.
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W0202101502009-05-01
EV3 INC.
HYPERGLIDE OCCLUSION BALLOON SYSTEM2009-04-16
ev3, Inc [Medtronic, Inc.]
NanoCross .014? OTW PTA2009-02-03
ev3, Inc [Medtronic, Inc.]
EverCross2008-12-10
ev3, Inc [Medtronic, Inc.]
EverCross .035? Over The Wire PTA Dilatation Catheter2008-12-10
ev3, Inc [Medtronic, Inc.]
EverCross .035? OTW PTA Dilatation Catheter2008-12-10
EV3 INC.
NANOCORSS .014 OTW PTA DILATATION CATHETER2008-12-04
EV3 INC.
EVERCROSS .035 OTW PTA DILATATION CATHETER2008-11-20
ev3, Inc [Medtronic, Inc.]
IntraStent2008-11-07
ev3, Inc [Medtronic, Inc.]
Protege RX GPS2008-11-07
ev3, Inc [Medtronic, Inc.]
Amplatz Thrombectomy Device2008-10-21
ev3, Inc [Medtronic, Inc.]
Amplatz Goose Neck Snare Kit/Cathet2008-10-21
ev3, Inc [Medtronic, Inc.]
BabyWire2008-10-21
ev3, Inc [Medtronic, Inc.]
SpiderFX Embolic Protection Device2008-10-21
ev3, Inc [Medtronic, Inc.]
PRIMUS GPS Biliary Stent (Visi-Pro)2008-10-21
ev3, Inc [Medtronic, Inc.]
Protege GPS Self-Expanding Stent2008-10-21
ev3, Inc [Medtronic, Inc.]
ParaMount Mini GPS Biliary Stent2008-10-21
ev3, Inc [Medtronic, Inc.]
Prot?g? Self-Expand Nitinol Stent2008-10-21
ev3, Inc [Medtronic, Inc.]
X-Sizer2008-10-21
ev3, Inc [Medtronic, Inc.]
IntraStent Mega/Max LD Stent, Bilia2008-10-21
ev3, Inc [Medtronic, Inc.]
ParaMount XS DoubleStrut Biliary2008-10-21
ev3, Inc [Medtronic, Inc.]
Protege EverFlex 5mm2008-08-18
ev3, Inc [Medtronic, Inc.]
Rinspirator2008-07-14
ev3, Inc [Medtronic, Inc.]
SilverHawk for Surgical Use2008-07-14
ev3, Inc [Medtronic, Inc.]
SilverHawk Peripheral Plaque Excisi2008-07-14
EV3 INC.
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-052008-03-18
ev3, Inc [Medtronic, Inc.]
IntraStent Double Strut Iliac2007-12-12
ev3, Inc [Medtronic, Inc.]
IntraCoil Self-expanding Peripheral2007-12-11
ev3, Inc [Medtronic, Inc.]
IntraStent DS XS, Biliary2007-12-11
ev3, Inc [Medtronic, Inc.]
PROTEGE GPS AND PROTEGE2007-02-08
ev3, Inc [Medtronic, Inc.]
PROTEGE GPS AND PROTEGE2007-02-08
EV3 INC
SPIDERFX EMBOLIC PROTECTION DEVICE2007-01-19
EV3 INC
SPIDERFX EMBOLIC PROTECTION DEVICE2006-11-14
EV3 INC
PRIMUS GPS BILIARY STENT SYSTEM2006-08-31
EV3 INC
SPIDERX EMBOLIC PROTECTION DEVICE2006-08-11
EV3 INC.
SPIDERX EMBOLIC PROTECTION DEVICE2006-06-23
EV3 INC.
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM2006-03-08
EV3 INC
SPIDERX EMBOLIC PROTECTION DEVICE2006-02-17
EV3 INC
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT2004-08-23
EV3 INC
PARAMOUNT MINI GPS BILIARY STENT SYSTEM2004-04-28
EV3 INC
MODIFICATION TO NITREX NITINOL GUIDEWIRE2004-03-02
EV3 INC
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM2003-11-21
EV3 INC
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM2003-11-17
EV3 INC
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM2003-10-22

Related Finance Registrations
NCAGE Code03NN1EV3 INC.!DBA COVIDIEN
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SEC0001318310ev3 Inc. of DELAWARE

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