Medtronic Vascular

FDA Filings

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

Medtronic Vascular holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3005364322
FEI Number3005364322
NameMedtronic Vascular
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3850 Brickway Blvd
Santa Rosa, CA 95403 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number1220452
FEI Number1220452
NameMEDTRONIC VASCULAR
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address37A Cherry Hill Dr
DANVERS, MA 01923 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only



Registration Number2953200
FEI Number3001452571
NameMedtronic Vascular
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3576 Unocal Pl
Santa Rosa, CA 95403 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Medtronic Vascular
Everest 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. T2022-04-13
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Taiga Guide Catheters2020-03-12
Medtronic Vascular [MEDTRONIC INC.]
IN.PACT? AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter2019-11-21
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Taiga Guide Catheter2019-09-25
Medtronic Vascular
Medtronic 6F Taiga Guiding Catheter2019-09-20
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Guardwire Carotid Embolic Protection Device2019-03-20
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX EndoAnchor System2018-11-26
Medtronic Vascular
Admiral Xtreme2018-04-12
Medtronic Vascular [MEDTRONIC INC.]
Sentrant Introducer Sheath with Hydrophilic Coating2018-01-02
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX EndoAnchor System2017-06-23
Medtronic Vascular [MEDTRONIC INC.]
Resolute Onyx Zotarolimus-Eluting Coronary Stent System2017-04-28
MEDTRONIC VASCULAR [MEDTRONIC INC.]
InTRAkit2016-11-21
Medtronic Vascular
InTRAkit2016-11-17
MEDTRONIC VASCULAR [MEDTRONIC INC.]
TRAcelet Compression Device2016-10-27
MEDTRONIC VASCULAR
TRAcelet Compression Device2016-10-21
MEDTRONIC VASCULAR [MEDTRONIC INC.]
DxTerity Catheter2016-08-29
MEDTRONIC VASCULAR
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak2016-08-19
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Everest Inflation Device2016-05-02
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Export Advance (new design)2016-04-11
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX EndoAnchor System2015-07-26
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX EndoAnchor System2015-07-26
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX EndoAnchor System2015-07-26
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX Thoracic EndoAnchor System2015-07-26
Medtronic Vascular [MEDTRONIC INC.]
Heli-FX EndoAnchor System2015-07-26
Medtronic Vascular [MEDTRONIC INC.]
Symplicity G3 Renal Denervation RF Generator Cart2015-04-10
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Attain2015-03-12
Medtronic Vascular [MEDTRONIC INC.]
IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter2014-12-30
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Cougar" Guidewire, Zinger" Guidewire, Thunder" Guidewire, ProVia" Guidewire, Intuition" Guidewire.2014-08-29
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Input PS Introducer2014-05-06
MEDTRONIC VASCULAR
TOTAL ACROSS2014-03-26
Medtronic Vascular [MEDTRONIC INC.]
Sentrant Introducer Sheath2013-05-03
MEDTRONIC VASCULAR
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING2013-04-26
MEDTRONIC VASCULAR
PACIFIC PLUS2013-01-29
MEDTRONIC VASCULAR [MEDTRONIC INC.]
10-11F Input TS Introducer2012-10-15
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Piton Y Adaptor, Piton Tri-Adaptor2012-10-15
MEDTRONIC VASCULAR [MEDTRONIC INC.]
PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool)2012-10-15
MEDTRONIC VASCULAR [MEDTRONIC INC.]
PTCA Accessory Pack (Y-Adaptor w/Hemostasis Valve, Stretch Insertion Tool, Steering Handle, Sterile Sleeve)2012-10-15
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Y-Connector with modified Touhy-Borst Adaptor, Stretch Insertion Tool2012-10-15
MEDTRONIC VASCULAR [MEDTRONIC INC.]
4F Siteseer Angiography Catheter2012-10-12
MEDTRONIC VASCULAR [MEDTRONIC INC.]
5F and 6F Siteseer Angiography Catheter2012-10-12
MEDTRONIC VASCULAR [MEDTRONIC INC.]
PWP Catheter2012-10-12
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Mullins Transeptal Catheter and Medtronic Transseptal Catheter Introducer Sheath2012-10-12
MEDTRONIC VASCULAR [MEDTRONIC INC.]
5F and 9F Zuma Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
8F Zuma Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
6F Zuma Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Everest 20 Inflation Device, Everest 20 Survival Kit2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Export XT and AP Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
5F and 8F Launcher Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
8F Sherpa NX Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
7F Sherpa NX Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
7F and 8F Launcher Biopsy Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
7F Launcher Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
6F Launcher Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
5F and 6F Z2 Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
7F Zuma Guiding Catheter2012-10-11
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Spring Safety (SOS) Guidewire2012-09-25
MEDTRONIC VASCULAR [MEDTRONIC INC.]
ProVia 15 Guidewire (Import for Export)2012-09-25
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Angiography Guide Wires (non-teflon coated)2012-09-25
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Woven Catheters2012-09-25
Medtronic Vascular [MEDTRONIC INC.]
Resolute Integrity Zotarolimus-Eluting Coronary Stent System2012-02-17
Medtronic Vascular [MEDTRONIC INC.]
Resolute Integrity MicroTrac Coronary Stent System2012-02-17
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Angiography Guide Wires - Multiple2011-10-28
Medtronic Vascular [MEDTRONIC INC.]
Valiant Thoracic Stent Graft System2011-04-12
Medtronic Vascular [MEDTRONIC INC.]
Valiant Navion Thoracic Stent Graft System2011-04-12
Medtronic Vascular [MEDTRONIC INC.]
Talent Occluder with Occluder Delivery System2010-12-22
Medtronic Vascular [MEDTRONIC INC.]
Endurant Stent Graft System2010-12-22
Medtronic Vascular [MEDTRONIC INC.]
Endurant IIs Stent Graft System2010-12-22
Medtronic Vascular [MEDTRONIC INC.]
Endurant II Stent Graft System2010-12-22
Medtronic Vascular [MEDTRONIC INC.]
Endurant II AUI Stent Graft System2010-12-22
Medtronic Vascular [MEDTRONIC INC.]
Archer Super Stiff Guidewire2010-09-02
MEDTRONIC VASCULAR
PIONEER PLUS CATHETER, MODEL PLUS 1202010-07-23
MEDTRONIC VASCULAR
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 152009-12-04
MEDTRONIC VASCULAR
6F TAIGA GUIDING CATHETER2009-02-06
MEDTRONIC VASCULAR
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES2009-02-06
MEDTRONIC VASCULAR
MEDTRONIC EXPORT AP CATHETER2008-06-27
Medtronic Vascular [MEDTRONIC INC.]
Integrity Coronary Stent System2007-12-10
Medtronic Vascular [MEDTRONIC INC.]
Integrity Coronary Stent System on MicroTrac Delivery System2007-12-10
Medtronic Vascular [MEDTRONIC INC.]
Reliant Stent Graft Balloon Catheter2007-12-07
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Everest 30 Inflation Device, Everest 30 Inflation Kit2007-11-02
MEDTRONIC VASCULAR [MEDTRONIC INC.]
4F-9F Input TS Introducer2007-11-02
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Rashkind Septostomy Catheter2007-11-02
MEDTRONIC VASCULAR
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB40142007-07-03
MEDTRONIC VASCULAR
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 608142007-06-18
MEDTRONIC VASCULAR
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 492612007-04-24
MEDTRONIC VASCULAR
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL742006-10-25
MEDTRONIC VASCULAR
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE2006-10-11
MEDTRONIC VASCULAR
5F SHERPA ACTIVE NX GUIDE CATHETER2006-09-08
MEDTRONIC VASCULAR
MEDTRONIC EXPORT XT CATHETER2006-09-05
MEDTRONIC VASCULAR
U-CLIP DEVICE, MODEL NC652006-08-02
MEDTRONIC VASCULAR
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R2006-05-23
MEDTRONIC VASCULAR
8F SHERPA NX GUIDE CATHETER2006-03-15
MEDTRONIC VASCULAR
6248VAL ADJUSTABLE VALVE2006-01-11
MEDTRONIC VASCULAR
U-CLIP DEVICE, MODELS B140, B160 AND B1802005-12-16
MEDTRONIC VASCULAR
MASTERGRAFT PUTTY BONE VOID FILLER2005-12-16
MEDTRONIC VASCULAR
TUNA SYSTEM, MODELS 8909, 8929, 8930, 89342005-11-17
MEDTRONIC VASCULAR
7F SHERPA NX GUIDE CATHETER2005-08-05
MEDTRONIC VASCULAR
MODIFICATION TO: EXPORT CATHETER2005-03-22
MEDTRONIC VASCULAR
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 608842004-12-21
MEDTRONIC VASCULAR
6F Z4 GUIDE CATHETER2004-12-13
MEDTRONIC VASCULAR
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR2004-12-03
MEDTRONIC VASCULAR
PURPLE/BLACK HEPARIN ASSAY CONTROL2004-10-18
MEDTRONIC VASCULAR
HEPARINASE HR ACT CONTROL, MODEL 550-122004-10-18
MEDTRONIC VASCULAR
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-202004-10-01
MEDTRONIC VASCULAR
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY2004-09-15
MEDTRONIC VASCULAR
MODEL 6416 TEMPORARY PACING LEAD SYSTEM2004-09-07
MEDTRONIC VASCULAR
DETECT SURGICAL PACING AND MAPPING TOOL2004-09-02
MEDTRONIC VASCULAR [MEDTRONIC INC.]
7F Export Catheter2004-08-26
MEDTRONIC VASCULAR
POLYGRAM NET BIOFEEDBACK APPLICATION2004-08-12
MEDTRONIC VASCULAR
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES2004-07-19
MEDTRONIC VASCULAR
EXPORT CATHETER2004-06-01
MEDTRONIC VASCULAR
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL22004-03-26
MEDTRONIC VASCULAR
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS2004-03-25
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Piton Y-Pack and Piton Tri-Pak, Torque Handle2004-03-09
MEDTRONIC VASCULAR
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 300112004-01-29
MEDTRONIC VASCULAR
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM2003-10-21
MEDTRONIC VASCULAR
EKG SPEAKS2003-10-15
MEDTRONIC VASCULAR
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER2003-10-09
MEDTRONIC VASCULAR
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR2003-09-11
MEDTRONIC VASCULAR
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS2003-09-03
MEDTRONIC VASCULAR
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB2003-07-31
MEDTRONIC VASCULAR
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM2003-07-17
MEDTRONIC VASCULAR
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH2003-07-17
MEDTRONIC VASCULAR
PACEART SYSTEM2003-05-29
MEDTRONIC VASCULAR
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,2003-05-22
MEDTRONIC VASCULAR
MODEL 5071 MYOCARDIAL PACING LEAD2003-05-22
MEDTRONIC VASCULAR
5F MEDTRONIC LAUNCHER GUIDE CATHETER2003-04-24
MEDTRONIC VASCULAR
MODIFICATION TO EXPORT ASPIRATION CATHETER2003-03-26
MEDTRONIC VASCULAR
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM2003-01-24
MEDTRONIC VASCULAR
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 771062003-01-08
MEDTRONIC VASCULAR
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY2002-12-30
MEDTRONIC VASCULAR
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY2002-12-30
MEDTRONIC VASCULAR
EXPORT ASPIRATION CATHETER2002-10-29
MEDTRONIC VASCULAR
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 106262002-10-09
MEDTRONIC VASCULAR
7F LAUNCHER GUIDE CATHETER2002-08-28
MEDTRONIC VASCULAR
PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM2002-08-28
MEDTRONIC VASCULAR
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT3002002-08-12
MEDTRONIC VASCULAR
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 62182002-05-30
MEDTRONIC VASCULAR
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A2002-05-30
MEDTRONIC VASCULAR
Z3 GUIDE CATHETER2002-05-17
MEDTRONIC VASCULAR
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 106002002-04-25
MEDTRONIC VASCULAR
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 608802002-01-25
MEDTRONIC VASCULAR
STENT SUPPORT GUIDE CATHETER2001-11-21
MEDTRONIC VASCULAR
ATTAIN 6215 VENOGRAM BALLOON CATHETER2001-08-28
MEDTRONIC VASCULAR
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM2001-08-28
MEDTRONIC VASCULAR
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 62182001-08-28
MEDTRONIC VASCULAR
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE2001-08-23
MEDTRONIC VASCULAR
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD2001-08-14
MEDTRONIC VASCULAR
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE2001-08-14
MEDTRONIC VASCULAR
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD2001-08-14
MEDTRONIC VASCULAR
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD2001-08-14
MEDTRONIC VASCULAR
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD2001-08-14
MEDTRONIC VASCULAR
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION2001-08-01
MEDTRONIC VASCULAR
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B2001-07-12
MEDTRONIC VASCULAR
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B2001-07-09
MEDTRONIC VASCULAR
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF2001-06-22
MEDTRONIC VASCULAR
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR2001-05-04
MEDTRONIC VASCULAR
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 62542001-04-05
MEDTRONIC VASCULAR
REVEAL PLUS INSERTABLE LOOP RECORDER2001-02-14
MEDTRONIC VASCULAR
STYLET KIT, MODELS 6254,6282,62932001-02-08
MEDTRONIC VASCULAR
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B2000-12-21
MEDTRONIC VASCULAR
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS3002000-08-16
MEDTRONIC VASCULAR [MEDTRONIC INC.]
Pro-Flo Angiography Catheter1995-01-30
MEDTRONIC VASCULAR [MEDTRONIC INC.]
6F Sherpa Guiding Catheter1995-01-30

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