FDA.reportPublic FDA data

ev3, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21838702183870ev3, Inc.1N2026-01-014600 Nathan Lane North Plymouth MN US 55442

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00199150028399Liberant™ - TUBING LMT -TRXV01 RIPTIDE+1(800)633-8766Corporate.UDI@medtronic.com
00821684071397Protégé™ GPS™ - STENT SERB65-09-20-120 PROTEGE GPS V05+1(800)633-8766Corporate.UDI@medtronic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
522581182749620P200026Abre Venous Self-expanding Stent SystemQAN2020-10-21
522581016057609P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
522581502379501P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
522581495882358P110023EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)NIP2012-03-07
522581379074213P060001PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMSNIM2007-01-24
522581312948322P030045INTRASTENT DOUBLESTRUT STENTNIO2004-06-08
522582062783362P000033INTRA COIL SELF-EXPANDING PERIPHERAL STENTNIP2002-04-03
522581460448131K993904INTRASTENT DOUBLESTRUT LDFGE2000-02-01
522581076267006K992816MODIFICATION TO INTRASTENTFGE1999-10-15
522581972217953K990592INTRASTENT IIFGE1999-09-01
522581128923576K982657AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100MCW1998-11-18
522581171003132K972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETERDXE1998-03-06
522581614153845K970668THE AMPLANTZ GOOSE NECK MICROSNAREDQY1998-06-10
522581732452758K914046THE BIG EASY Y-ADAPTERDYB1991-11-08
522581174102335K895899FLEXMEDICS GUIDEWIRE .012 ONLYDQX1990-05-23
522582067533228K241259Amplatz Goose Neck Snare KitMMX2024-06-03
522581922414013K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterGEI2023-03-23
522581430055291K213631Chocolate PTA Balloon CatheterLIT2021-12-15
522581385785360K212027TurboHawk Plus Directional Atherectomy SystemMCW2021-08-24
522581419553286K202800Pacific Plus PTA CatheterLIT2020-11-18
522581401339114K192966FlowMetDPW2020-01-10
522581795368547K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterLIT2019-04-23
522581804196931K173515Admiral XtremeLIT2018-04-12
522581082791189K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW2017-06-16
522581367144920K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW2017-06-16
522581110727857K162384TrailBlazer Angled Support CatheterDQY2016-09-22
522581510367691K161361HawkOne Directional Atherectomy SystemMCW2016-10-14
522581563783015K161361HawkOne Directional Atherectomy SystemMCW2016-10-14
522581760654487K150108Reverse Medical Micro Vascular Plug SystemKRD2015-04-22
522581554584230K142654Fortrex 0.035 OTW PTA Balloon CatheterLIT2014-10-28
522581983644847K141858CLOSURERFG RADIOFREQUENCY GENERATORGEI2014-08-05
522581303453593K141801HAWKONE DIRECTIONAL ATHERECTOMY SYSTEMMCW2014-10-16
522581767582409K141801HAWKONE DIRECTIONAL ATHERECTOMY SYSTEMMCW2014-10-16
522581594262849K141313REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEMKRD2014-06-18
522581373262637K141118NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETERLIT2014-07-18
522581964893849K133282REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEMKRD2013-11-27
522581312043300K132777NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETERLIT2013-09-26
522581682344118K130911RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETERLIT2013-05-24
522581017745293K130414CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018LIT2013-06-15
522581482025563K123803REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEMKRD2013-07-02
522581755666777K123544RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETERLIT2013-02-12
522581490543887K123358PACIFIC PLUSLIT2013-01-29
522581789367953K121745MANTARAY GUIDEWIRESDQX2012-07-13
522581477616218K120881MANTARAY GUIDEWIRESDQX2012-04-18
522581867525031K120863WHOLEY GUIDE WIRE SYSTEMDQX2012-04-19
522581506278324K120533BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRESPDU2012-05-22
522581728282999K120129MANTARAY CATHETERDQY2012-02-03
522582043119539K113589BIGBOSS CATHETERDQY2012-01-04
522581709944726K113289ORION MICRO CATHETERKRA2012-08-01
522581565817661K111963BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETERDQY2011-08-10
522581620982080K111887CLOSUREFAST RADIOFREQUENCY CATHETERGEI2011-09-09
522581788230172K111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2011-10-27
522581753899090K111488MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003DQX2011-06-30
522581880157678K111010SPIDERFX EMBOLIC PROTECTION DEVICENTE2011-10-27
522581242428359K110319EVERCROSS 0.035 OTW PTA DILATATION CATHETERLIT2011-04-14
522581603047240K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMMCW2011-01-05
522581714689169K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMMCW2011-01-05
522581143739567K103322EVERCROSS 0.035 OTW PTA DILATION CATHETERLIT2010-12-06
522581354516207K100921ADMIRAL XTREME PTA BALLOON DILATATION CATHETERLIT2010-04-30
522581541123291K093301TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2009-11-06
522582033313508K093286POWERCROSS .018 OTW PTA DILATION CATHETERLIT2009-11-13
522582062364738K092299TRAILBLAZER SUPPORT CATHETERDQY2009-08-07
522581589755247K092177MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6NTE2009-10-15
522581394786181K090849MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150DQY2009-05-01
522581544015877K083919AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERDQY2009-03-13
522581610044220K082854NANOCORSS .014 OTW PTA DILATATION CATHETERDQY2008-12-04
522581165265294K082579EVERCROSS .035 OTW PTA DILATATION CATHETERDQY2008-11-20
522581838175564K073627FLEXOR EVAC ASPIRATION CATHETERQEZ2008-03-04
522581126080015K0723015MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05FGE2008-03-18
522581490151612K071826THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910QEZ2007-11-09
522581624338813K071432SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USEMCW2008-02-12
522581758741750K063785SPIDERFX EMBOLIC PROTECTION DEVICENFA2007-01-19
522581737150366K063204SPIDERFX EMBOLIC PROTECTION DEVICENTE2006-11-14
522581452461968K062809ADMIRAL XTREME PTA CATHETERDQY2006-10-18
522581063298177K061566PRIMUS GPS BILIARY STENT SYSTEMFGE2006-08-31
522581809569933K061373VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100GEI2006-08-01
522581361290882K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2006-10-23
522581894259874K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2006-10-23
522581205256385K060057PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEMFGE2006-03-08
522581816284960K053460MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,MCW2006-01-13
522581853965254K052791MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERDQY2005-11-04
522581226874889K052003VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)GEI2005-10-11
522581477731889K051379PROTEGE RX GPS SELF-EXPANDING NITRINOL STENTFGE2005-06-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LIT242021-12-15
FGE232008-03-18
DQY192016-09-22
MCW182021-08-24
DQX142012-07-13
GEI112023-03-23
NTE52011-10-27
KRD42015-04-22
QEZ32008-03-04
PJQ22015-02-20
PDU22012-05-22
NIP22012-03-07
NIM22007-01-24
NFA22007-01-19
NIO22004-06-08
DXE21998-03-06
DYB21991-11-08
MMX12024-06-03
QAN 12020-10-21
DPW12020-01-10
KRA12012-08-01

PMA#

PMN#

41 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next