FDA.reportPublic FDA data

BARD PERIPHERAL VASCULAR, INC.

Matched from indexed company URL: Bard Peripheral Vascular

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20203942020394BARD PERIPHERAL VASCULAR, INC.1Y2026-01-011625 W 3rd St TEMPE AZ US 85281

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
00801741234156EnCor EnCompass™ - EnCor EnCompass™ Breast Biopsy and Tissue Removal System Sample Container+1(800)321-4254medical.services@BD.com
00801741234163EnCor EnCompass™ - EnCor EnCompass™ Breast Biopsy and Tissue Removal System MRI Extension Tubing+1(800)321-4254medical.services@BD.com
00801741234187EnCor EnCompass™ - EnCor EnCompass™ Breast Biopsy and Tissue Removal System Canister Liner Bag+1(800)321-4254medical.services@BD.com
00801741234194EnCor EnCompass™ - EnCor EnCompass™ Breast Biopsy and Tissue Removal System Stereotactic Adapter+1(800)321-4254medical.services@BD.com
00801741236167EnCor EnCompass™ - EnCor EnCompass™ Breast Biopsy and Tissue Removal System VisiLoc™ MRI Introducer Set 10G+1(800)321-4254medical.services@BD.com
10801741234153EnCor EnCompass™ - EnCor EnCompass™ Breast Biopsy and Tissue Removal System Sample Container+1(800)321-4254medical.services@BD.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
360571759294480P180037Venovo Venous Stent SystemQAN2019-03-13
360571489855055P170042Covera™ Vascular Covered StentPFV2018-07-30
360571549833751P160024LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENTPRL2017-04-24
360571977743193P130029FLUENCY PLUS ENDOVASCULAR STENT GRAFTPFV2014-06-17
360571001387635P080007BARD E-LUMINEXX VASCULAR STENTNIO2008-12-04
360571319940737P070014LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEMNIP2009-02-13
360571979670699P060002FLAIR ENDOVASCULAR STENT GRAFTPFV2007-07-23
360571172894015K993785ULTRACLIP TISSUE MARKERGDW2000-02-04
360571406886467K991280125 IMPLANT SEEDS, MODEL STM1251KXK1999-10-20
360571453107310K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
360571282329718K983861DISTAFLO BYPASS GRAFTDSY1998-11-24
360571519549676K983769DISTAFLO BYPASS GRAFTDYF1998-12-15
360572011477985K972152DEVMED STEPPING AND STABILIZING SYSTEMITX1997-08-15
360571133990381K970099SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMDTK1997-04-16
360571937997433K962907SKINNY,FRANSEEN,WESCOTT NEEDLESKNW1996-10-23
360571333831824K962077BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACERKNW1996-07-30
360571945453137K936194COAXIAL BIOPSY NEEDLEFCG1994-03-22
360571073109029K934371BIP MULTI MODIFICATIONKNW1994-04-28
360571505165304K934370BIP BIOPSY NEEDLE MODIFICATIONFCG1994-03-07
360571164952564K930217BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLEFMI1994-02-28
360571446799131K915801BIP-COAX-SYSTEMFCG1994-03-11
360571751235665K913306BONE-TEMNO/STERNUM-TEMNOLWE1991-11-01
360571718468319K905073CARDIOVASCULAR REPAIR PATCHDXZ1991-12-20
360571748241025K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
360571682969405K843083CORMED HUBER POINT NEEDLEGAA1984-09-05
360571899218900K830471KELLY-WICK TANNELERDWS1983-03-24
360571318321756K813338BIOPSY NEEDLES & TRAYSFSH1982-01-28
360571800074813K770835PATCH FABRICDXZ1977-10-05
360571849917475K770235DEBAKEY VASCULOUR-D PROSTHESESDSY1977-02-24
360571249502382K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemKNW2025-12-12
360571232733940K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)GEI2025-08-19
360571113812612K250068Venclose digiRF Generator (VCRFG1)GEI2025-02-04
360571989753253K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitKNW2025-07-10
360571339592358K243642UltraCor™ Twirl™ Breast Tissue MarkerNEU2025-03-24
360571398370702K242757Rotarex Atherectomy SystemMCW2025-01-30
360571594700444K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-PNG2024-12-06
360571414125310K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitDTK2024-02-29
360572018243015K230356Aspirex™ Thrombectomy SystemQEW2023-03-31
360571178139770K223177Highlander™ 014 PTA Balloon Dilatation CatheterLIT2023-01-20
360571916396666K222793WavelinQ™ GeneratorGEI2022-10-17
360571437386442K221440Liverty™ TIPS Access SetDYB2022-05-31
360571323411502K220270Aspirex Thrombectomy SystemQEW2022-06-21
360571132978604K213896BD Trek Powered Bone Biopsy SystemKNW2022-03-30
360571306025844K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty CatheterDQY2022-05-04
360571577739406K211933EleVation Breast Biopsy SystemKNW2021-07-15
360571522886931K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven CatheterGEI2021-08-03
360572035653455K211738Rotarex Atherectomy SystemMCW2021-09-14
360571809796878K211410GlidePath 13F Long-Term Hemodialysis CatheterMSD2021-06-04
360571768956006K210654EnCor Breast Biopsy Probe with Rinse TubeKNW2021-03-31
360571343135543K203767Pristine Long-Term Hemodialysis CatheterMSD2021-04-02
360571502809498K203575GlidePath Retro Long-Term Hemodialysis CatheterMSD2021-07-01
360571605684143K203363Crosser iQ CTO Recanalization SystemPDU2021-08-12
360571663869683K203275Recon Support CatheterDQY2021-03-01
360571934286645K202150GlidePath 7.5F Long-Term Dialysis CatheterMSD2020-11-18
360571840127525K200627GlidePath 10F Long-Term Dialysis CatheterMSD2020-06-22
360571421405083K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14GKNW2019-11-07
360571569668445K192318Ultraverse 014 and 018 PTA Balloon Dilatation CathetersLIT2019-10-03
360571735491724K192239WavelinQ Plus EndoAVF SystemPQK2019-10-17
360571927278284K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesKRD2020-02-04
360571239152177K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis CathetersMSD2020-03-05
360571644749500K182796WavelinQ 4F EndoAVF SystemPQK2019-02-06
360571865451284K181323Atlas Gold PTA Dilatation CatheterLIT2018-08-03
360571267348653K180061UltraCor Twirl Breast Tissue MarkerNEU2018-03-09
360571921950510K172932True Flow Valvuloplasty Perfusion CatheterOZT2017-12-13
360572033661898K172571ULTRASCORE Focused Force PTA BalloonPNO2017-09-22
360571346327071K172315Straub Endovascular SystemMCW2018-04-12
360571125162429K171953Bard Mission Disposable Core Biopsy InstrumentKNW2017-09-14
360571395361296K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleKNW2017-09-11
360571594950991K162656ESU-1 Electrosurgical GeneratorGEI2016-11-10
360571474493080K161986SIDEKICK and USHER Support CathetersDQY2016-08-04
360571347640664K161805EnCor MRI Introducer Set, EnCor Probe IntroducerKNW2016-07-19
360571783837013K161208CROSSER CTO Recanalization CatheterPDU2016-05-24
360571600976819K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)GEI2016-09-09
360571189012553K152510UltraCor Twirl Breast Tissue MarkerNEU2016-05-13
360571517828757K152136Recovery Cone Removal SystemMMX2016-02-18
360571133975231K150667True Dilatation Balloon Valvuloplasty CatheterOZT2015-06-17
360571928289305K143522Presto Inflation DeviceMAV2015-01-12
360571114778912K142261Ultraverse 035 PTA Balloon Dilatation CatheterLIT2014-09-24
360571113230798K141985TRUE BA V BALLOON VALVULOPLASTY CATHETEROZT2014-09-18
360572031824650K140856BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPSKXK2014-05-02
360571388394431K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTKNW2014-02-21
360571710493273K131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERNEU2013-06-27
360571334526697K131493SIDEKICK AND USHER SUPPORT CATHETERSDQY2013-08-02
360571585242135K131199ULTRAVERSE RX PTA BALLOON DILATATION CATHETERLIT2013-05-30
360571354303407K131002VIDA PTV DILATATON CATHETEROMZ2013-07-02
360571183885759K130792LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEMFGE2013-08-30
360571480666815K130366BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KITDTK2013-05-15
360571185799908K123911SENOMARK ULTRA BREAST TISSUE MARKERNEU2013-01-10
360571994752367K121856ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSIONLIT2012-07-11
360571114285335K120971ATLAS PTA BALLOON DILATATION CATHETERLIT2012-04-19
360571963754324K120722RIVAL PTA DILATATION CATHETERLIT2012-04-19
360571798129581K120660CONQUEST 40 PTA DILATATION CATHETERLIT2012-03-15
360572047683441K112308CROSSER RECANALIZATION SYSTEMPDU2011-08-17
360571611209744K111850VACCESS PTA DILATATION CATHETERDQY2011-07-13
360571355619215K111100ENCOR ENSPIRE BREAST BIOPSY SYSTEMKNW2011-06-16
360571625325896K110409ASPIRA PLEURAL DRAINAGE SYSTEMDWM2011-05-11
360571676854290K110396ASPIRA PERITONEAL DRAINAGE SYSTEMPNG2011-05-06
360571773330096K103459VASCUTRAK PTA DILATATION CATHETERPNO2010-12-13
360571176501072K103367SEEKER CROSSING SUPPORT CATHETERDQY2010-12-08
360571344235419K103359FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)KNW2010-12-27
360571997379975K093663RADIONUCLIDE BRACHYTHERAPY SOURCEKXK2009-12-23
360571576263578K093068FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105USKNW2009-11-10
360571658740171K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100DXT2009-06-19
360571246545340K090547ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017UNEU2009-03-18
360571851070809K083657CONQUEST PTA BALLOON DILATATION CATHETERDQY2008-12-24
360571831106899K082681VACORA VACUUM ASSISTED BIOPSY SYSTEMKNW2008-10-15
360571408695042K082094BARD PTFE (TEFLON) COATED GUIDE WIRESDQX2008-12-17
360571397060076K081288ASPIRA PERITONEAL DRAINAGE SYSTEMPNG2008-07-18
360571629889516K080849MICROSHEATH LP AND LP-ATDQY2008-07-25
360571035541534K072283DORADO PTA BALLOON DILATATION CATHETERDQY2007-09-19
360571626968462K071095ASPIRA PLEURAL DRAINAGE SYSTEMDWM2007-05-18
360571912208786K063532BARD E LUMINEXX BILIARY STENTFGE2008-05-30
360571893984755K063238ULTRACLIP II WING AND ULTRACLIP II COILNEU2007-01-30
360572033851700K060636PALLADIUM-103 SEED IMPLANT KITS -MULTIPLEKXK2006-04-19
360571467465479K060487LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEMFGE2006-03-23
360571992171367K053404LIFESTENT FLEXSTART BILIARY STENT SYSTEMFGE2005-12-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNW212025-12-12
NEU102025-03-24
GEI92025-08-19
LIT92023-01-20
DQY92022-05-04
KXK82014-05-02
MSD62021-07-01
FGE52013-08-30
DSY52005-09-20
PFV42018-07-30
MCW32025-01-30
PNG32024-12-06
DTK32024-02-29
PDU32021-08-12
PQK32019-10-17
OZT32017-12-13
FCG31994-03-22
QEW22023-03-31
DYB22022-05-31
PNO22017-09-22
MAV22015-01-12
DWM22011-05-11
DXT22009-06-19
GDW22004-06-03
ITX22003-05-20
DYF22001-05-14
FMI21994-02-28
DXZ21991-12-20
KRD12020-02-04
QAN12019-03-13
PRL12017-04-24
MMX12016-02-18
OMZ12013-07-02
NIP12009-02-13
DQX12008-12-17
NIO12008-12-04
KCT12004-09-30
IZD12002-02-06
FZP12001-07-16
LWE11991-11-01

PMA#

Venovo™ Venous Stent System

2023-02-02

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS012 Date Received01/06/2023 Decision Date02/02/2023 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

LifeStent™ 5F Vascular Stent Systems

2023-02-02

BARD PERIPHERAL VASCULAR, INC.1415 West 3rd St.tempe, AZ 85281 PMA NumberP070014 Supplement NumberS064 Date Received01/06/2023 Decision Date02/02/2023 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

LifeStream® Balloon Expandable Vascular Covered Stent

2022-08-23

BARD PERIPHERAL VASCULAR, INC.1625 West 3rd St.tempe, AZ 85281-1740 PMA NumberP160024 Supplement NumberS012 Date Received02/24/2022 Decision Date08/23/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee S...

Bard E- Luminexx Vascular Stent System

2022-05-26

BARD PERIPHERAL VASCULAR, INC.1415 West 3rd St.tempe, AZ 85281 PMA NumberP080007 Supplement NumberS027 Date Received05/02/2022 Decision Date05/26/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Venovo Venous Stent System

2022-05-23

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS011 Date Received05/19/2022 Decision Date05/23/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

Venovo Venous Stent System

2022-05-20

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS010 Date Received04/26/2022 Decision Date05/20/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

Venovo Venous Stent System

2022-04-22

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS009 Date Received03/25/2022 Decision Date04/22/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

159 records. Showing 1-40. Next

PMN#

GUDID#

80 records. Showing 1-40. Next