FDA.report

ABBOTT VASCULAR

Matched from indexed company URL: Abbott Vascular

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
20241682024168ABBOTT VASCULAR1Y2026-01-0126531 YNEZ RD. Temecula CA US 92591
29395613004635528ABBOTT VASCULAR1N2026-01-013200 Lakeside Dr SANTA CLARA CA US 95054
30050704063005070406Abbott Vascular1N2026-01-013885 Bohannon Drive Menlo Park CA US 94025
30057185703005718570ABBOTT VASCULAR1N2026-01-01CASHEL ROAD CLONMEL Tipperary IE ,
30057376523005737652ABBOTT VASCULAR1N2026-01-01Building PR-17, Road #2, km 58.0, Cruce Davila Barceloneta PR US 00617

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
08717648353765Esprit™ - Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 28mm Over-The-Wire+1(800)227-9902john3103@gmail.com
08717648353765Esprit™ - Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 28mm Over-The-Wire+1(800)227-9902av.customercare@av.abbott.com
08717648353789Esprit™ - Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 38mm Over-The-Wire+1(800)227-9902john3103@gmail.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
21491971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
21501971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
21591971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
21491867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
21501867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
21591867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
21491961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
21591961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
1234461118222661P230007TriClip G4 SystemNPS2024-04-01
21491457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
21591457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
21491067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21591067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21491792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21501792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21591792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21491309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
21591309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
21491542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21501542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21591542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21491469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
21591469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
21491128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21591128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
1234461128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21491727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21501727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21591727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21491559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
21501559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
21591559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
21491681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
21591681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
21491479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
21591479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
21491963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
21501963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
21591963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
21491233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
21591233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
21491589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
21591589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
21491208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
21591208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
21491267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
21591267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
21491757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
21591757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
21491210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
21591210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
21491576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
21591576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
21491412691795K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQX1998-03-13
21591412691795K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQX1998-03-13
21491887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
21591887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
20912053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21492053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21592053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21491439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
21591439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
21491725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
21591725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
21491879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
21591879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
21491748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
21591748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
21491469853050K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQX1995-04-05
21591469853050K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQX1995-04-05
21491449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
21591449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
21491092773492K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVEDYB1994-04-13
21591092773492K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVEDYB1994-04-13
21491429531772K934602ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIREDQX1993-12-16
21591429531772K934602ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIREDQX1993-12-16
21491155385726K934339LOC GUIDE WIRE EXTENSIONDQX1993-12-09
21591155385726K934339LOC GUIDE WIRE EXTENSIONDQX1993-12-09
21491956546163K931171DOC-TITE(TM) GUIDE WIRE EXTENSIONDQX1993-06-04
21591956546163K931171DOC-TITE(TM) GUIDE WIRE EXTENSIONDQX1993-06-04
20911452023796K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIREDQX1993-02-12
21491452023796K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIREDQX1993-02-12
21591452023796K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIREDQX1993-02-12
21491071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
21491820946517K913631.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIREDQX1991-10-28
21591820946517K913631.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIREDQX1991-10-28
21491791893216K913353VASCULAR GUIDE WIREDQX1991-10-23
21591791893216K913353VASCULAR GUIDE WIREDQX1991-10-23
21491900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
21591900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
21492019477494K902755.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIPDQX1990-09-04
21592019477494K902755.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIPDQX1990-09-04
21491637217174K881897ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GWDQX1988-08-03
21591637217174K881897ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GWDQX1988-08-03
21491229520279K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIREDQX1988-07-25
21591229520279K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIREDQX1988-07-25
21491708793242K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDF1988-02-12
21491269826574K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVESDTL1985-12-04
21591269826574K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVESDTL1985-12-04
21491263121909K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)NQQ2026-04-24
21491107932852K252512Armada™ 14 NC PTA CatheterLIT2026-02-13
21501107932852K252512Armada™ 14 NC PTA CatheterLIT2026-02-13
21591107932852K252512Armada™ 14 NC PTA CatheterLIT2026-02-13
1234461780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
1234461430420592K241538TriClip Steerable Guide CatheterDQY2024-08-26
20911358873035K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX2024-11-06
21491358873035K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX2024-11-06
21591358873035K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX2024-11-06
21491866209065K232458JETi™Hydrodynamic Thrombectomy SystemQEZ2023-12-19
21491362972053K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6NQQ2023-09-08
21491902982090K230411Dragonfly OpStar™ Imaging CatheterDQO2023-04-14
1234461033547631K221397MitraClip G4 Steerable Guide CatheterDRA2022-09-28
21491662996101K221057Viatrac 14 Plus Peripheral Dilatation CatheterLIT2022-05-05
21591662996101K221057Viatrac 14 Plus Peripheral Dilatation CatheterLIT2022-05-05
21491429962158K220634NC TREK NEO Coronary Dilatation CatheterLOX2022-06-30
21591429962158K220634NC TREK NEO Coronary Dilatation CatheterLOX2022-06-30
21491102114316K220243Ultiri Measurement SystemDQK2022-04-30
21491242710329K213565JETi AIO Peripheral Thrombectomy SystemQEZ2022-02-01
21491967538092K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemNQQ2021-06-08

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQX1062024-11-06
LOX182022-06-30
LIT152026-02-13
NQQ112026-04-24
DRA112022-09-28
MAF72003-07-16
DQY62024-12-31
NTE62019-07-25
LDF62016-11-22
NIQ62011-11-01
FGE62008-08-18
MGB62005-12-21
DTL41999-06-09
MAV41996-09-12
DQO32023-04-14
NKM32013-10-24
NIO 32012-07-31
QEZ22023-12-19
DQK22022-04-30
DXO22018-03-28
PNY22016-07-05
NIP22014-03-28
NIO22012-02-22
NIN 22011-07-20
NIM22005-09-06
NIM 22004-08-30
DYB21994-04-13
DSA21991-05-07

PMA

Supera Peripheral Stent System

2023-01-31

ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS030 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIP  Advisory Committee Cardiovascular Supplement Type135 Review Track For 3...

XACT Carotid Stent System

2023-01-31

ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040038 Supplement NumberS041 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supple...

StarClose SE Vascular Closure System

2023-01-31

ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS043 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Sup...

Absolute Pro Vascular Self-Expanding Stent System

2023-01-31

ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 92054 PMA NumberP110028 Supplement NumberS023 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIO  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supple...

RX Acculink Carotid Stent System

2023-01-31

ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040012 Supplement NumberS064 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement ...

Supera Peripheral Stent System Nylon Pouch

2022-12-20

ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS029 Date Received09/30/2022 Decision Date12/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Typereal-time Process Supp...

StarClose SE Vascular Closure System

2022-12-16

ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS042 Date Received11/16/2022 Decision Date12/16/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...

Supera Peripheral Stent System

2022-11-22

ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS028 Date Received09/30/2022 Decision Date11/22/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Typereal-time Process Supp...

Omnilink Elite™ Vascular Balloon-Exoandable Stent System

2022-09-07

ABBOTT VASCULAR-CARDIAC THERAPIES3200 Lakeside Dr.santa Clara, CA 95054-2807 PMA NumberP110043 Supplement NumberS013 Date Received08/09/2022 Decision Date09/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement ...

MULTI-LINK RX ULTRA™ Coronary Stent System

2022-09-07

ABBOTT VASCULAR INC.26531 Ynez Roadtemecula, CA 92591 PMA NumberP970020 Supplement NumberS086 Date Received08/09/2022 Decision Date09/07/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

XACT Carotid Stent System

2022-07-13

ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040038 Supplement NumberS040 Date Received06/14/2022 Decision Date07/13/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

XIENCE Skypoint Everolimus Eluting Coronary Stent System

2022-06-22

ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP110019 Supplement NumberS121 Date Received05/23/2022 Decision Date06/22/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

XIENCE Skypoint Everolimus Eluting Coronary Stent System

2022-05-06

ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP110019 Supplement NumberS120 Date Received04/06/2022 Decision Date05/06/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Re...

RX Herculink Elite Renal Stent System

2022-03-24

ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP110001 Supplement NumberS018 Date Received02/28/2022 Decision Date03/24/2022 Product Code NIN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

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PMN

61 records. Showing 1-40. Next

GUDID

80 records. Showing 1-40. Next