FDA.reportPublic FDA data

MEDTRONIC VASCULAR

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12204521220452MEDTRONIC VASCULAR1N2026-01-0137A Cherry Hill Dr DANVERS MA US 01923
29532003001452571Medtronic Vascular1N2026-01-013576 Unocal Pl Santa Rosa CA US 95403
30053643223005364322Medtronic Vascular1N2020-04-253850 Brickway Blvd Santa Rosa CA US 95403

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58151366141209P220026Symplicity Spyral™ Renal Denervation SystemQYI2023-11-17
58151840090773P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterPRC2019-11-21
58151509855441P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2017-04-28
58152046408222P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU2014-12-30
58151715533001P110013RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2012-02-17
1484311598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
58151598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
1484311783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
58151783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
58151126185707P030009DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMSMAF2003-10-01
57631950599349P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMLWP2001-08-28
57631406554786K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSDQY1999-03-22
57631443649876K984627AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETERDQO1999-07-27
57631057136928K982883MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETERDQY1998-09-04
57631200201418K981198MEDTRONIC ZUMA GUIDING CATHETERDQY1998-08-07
57631140458554K961135INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)DYB1996-04-30
57631893498806K960983MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KITMAV1996-05-30
57631797967388K960056USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHICDQO1996-10-23
57631006617083K955785TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SETDYB1996-03-12
57631474129857K945461PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)DTL1995-02-03
57631069305707K942269MEDTRONIC EVEREST INFLATION DEVICEMAV1994-10-18
57631472401602K940063MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKSLIT1994-03-29
57631378988972K932092USCI ANGIOGRAPHIC CATHETERDQO1993-07-29
57631661635563K923638ACESSORY PACKLIT1993-02-08
57631026569641K890325USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAPLIT1989-03-15
57631220831835K884065CATH LAB MONITORING CATHETERDQO1989-01-12
57631243401250K832607OPEN END SPRING GUIDEDQX1983-12-27
57631694665164K791963USCI MULLINS TRANSSEPTAL CATHETER INTRO.DYB1979-11-13
57631645146415K253589Liberant™ RX Aspiration CatheterQEZ2026-04-23
58151844304635K232570Steerant™ Super Stiff GuidewireDQX2023-10-24
57631909211761K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterDQY2023-08-22
57631730798914K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterDQY2023-06-30
57631225086674K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)MAV2022-04-13
57631351502273K192296Medtronic 6F Taiga Guiding CatheterDQY2019-09-20
1484311882649965K182957Heli-FX EndoAnchor SystemOTD2018-11-21
58151882649965K182957Heli-FX EndoAnchor SystemOTD2018-11-21
1484311118090421K171866Sentrant Introducer Sheath with Hydrophilic CoatingDYB2017-12-20
58151118090421K171866Sentrant Introducer Sheath with Hydrophilic CoatingDYB2017-12-20
1484311460978462K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD2017-06-13
58151460978462K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD2017-06-13
57631553400710K162097InTRAkitDYB2016-11-17
57631428767269K162027TRAcelet Compression DeviceDXC2016-10-21
57631033813229K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakDQO2016-08-19
57631277860641K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMAV2016-04-13
57631949864866K152335Export Advance Aspiration CatheterDXE2015-09-18
57631384996647K143316Attain Hybrid Guide WireDQX2015-03-11
1484311057314531K141041APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTEOTD2014-05-16
58151057314531K141041APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTEOTD2014-05-16
57631848119186K140695COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIREDQX2014-06-12
1484311955107921K140036APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITHOTD2014-02-06
58151955107921K140036APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITHOTD2014-02-06
57631461109560K1326735F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETERDQY2013-10-22
57632006625879K132617MEDTRONIC INPUT PS INTRODUCERDYB2014-04-30
58151051179292K130677APTUS HELI-FX AORTIC SECUREMENT SYSTEMOTD2013-04-12
1484311051179292K130677APTUS HELI-FX AORTIC SECUREMENT SYSTEMOTD2013-04-12
1484311688545531K123990SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATINGDYB2013-04-26
58151688545531K123990SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATINGDYB2013-04-26
1484311161892193K121168APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTHOTD2012-08-08
58151161892193K121168APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTHOTD2012-08-08
57631066065985K120808EXPORT XT CATHETER, EXPORT AP CATHETERQEZ2012-06-07
57631596744547K103386MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERSDQY2011-02-11
1484311619289091K101339ARCHER SUPER STIFF GUIDEWIRESDQX2010-08-31
57631396797612K082873MEDTRONIC ANGIOGRAPHIC GUIDE WIRESDQX2009-02-06
57631037362464K0604188F SHERPA NX GUIDE CATHETERDQY2006-03-15
57631636566116K0518467F SHERPA NX GUIDE CATHETERDQY2005-08-05
57632019374701K050139MODIFICATION TO: EXPORT CATHETERQEZ2005-03-22
1484311138681535K050038RELIANT STENT GRAFT BALLOON CATHETERDQY2005-04-13
58151138681535K050038RELIANT STENT GRAFT BALLOON CATHETERDQY2005-04-13
57631212296791K0424896F Z4 GUIDE CATHETERDQY2004-12-13
57631623880972K030671MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBBDQY2003-07-31
57631433137689K0227647F LAUNCHER GUIDE CATHETERDQY2002-08-28
57631785736813K021256Z3 GUIDE CATHETERDQY2002-05-17
57631955378795K010579STENT SUPPORT GUIDE CATHETERDQY2001-11-21
57631399376264K000677ZUMA GUIDE CATHETERSDQY2000-03-29
1484311154191734DEN100026APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTEOTD2011-11-21
58151154191734DEN100026APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTEOTD2011-11-21
57631323465383
57631543966362
57631639762632
57631922760309
58151088029837
57631620441955
57631793134019

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY182023-08-22
OTD142018-11-21
DYB92017-12-20
DQX62023-10-24
DQO62016-08-19
MAV42022-04-13
MIH42011-04-01
QEZ32026-04-23
LIT31994-03-29
NIQ22017-04-28
PRC12019-11-21
DXC12016-10-21
DXE12015-09-18
ONU12014-12-30
MAF12003-10-01
LWP12001-08-28
DTL11995-02-03

PMA#

200 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next