ABBOTT VASCULAR

FDA Device Registration & Listing · Temecula, CA, US · Registration 2024168

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2024168
FEI Number
2024168
Entity Name
ABBOTT VASCULAR
City/State/Country
Temecula, CA, US
Establishment Address
26531 YNEZ RD., Temecula, CA 92591, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

XIENCE V Everolimus Eluting Coronar Xience V Xience Nano XIENCE V, RX Drug Eluting Stent System XIENCE V, OTW Drug Eluting Stent System Armada 14 NC PTA Catheter Pacel Bipolar Pacing Catheter Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764 RX Herculink Elite Renal Stent System HT SPARTACORE HT STEELCORE HT SUPRA CORE Hi-Torque BMW Elite Guide Wire Hi-Torque VersaTurn Flex Guide Wire Hi-Torque VersaTurn Ultraflex Guide Wire Hi-Torque VersaTurn Guide Wire JETi Hydrodynamic Thrombectomy System Ultra RX Armada 14 PTA Catheter X.act Carotid Stent System Xact Carotid Stent System XACT Transcarotid Stent System Mini Trek OTW Mini Trek RX Mini Trek II OTW PressureWire X HT Command 14 ST HT Command 14 MT RX Herculink Elite Biliary Stent Sy Ultiri Measurement System Rotating Hemostatic Valve Hi-Torque Wiggle Guide Wire DOC Guide Wire Extension ILUMIEN System ILUMIEN Guided Therapy System ILUMIEN Therapy Guidance System Hi-Torque Steelcore Guide Wire Hi-Torque Steelcore 18 Guide Wire Dragonfly OpStar™ Imaging Catheter. ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2 ILUMIEN Systems with AptiVue Software Version D.3 E.4 Metallis Stent Optimization E.4 SW NC TREK RX Coronary Dilatation Catheter Rotating Hemostatic Valve (.115) NC TREK OTW CORONARY DILATATION CATHETER Hi-Torque BMW Universal II Guide Wire Hi-Torque BMW Universal II Hi-Torque Traverse Guide Wire Hi-Torque Supra Core Guide Wire ILUMIEN OPTIS System and Accessories PPAK 20/30 w/.115 RHV 20/30 Indeflator 20/30 PPAK with Bleedback Control Valve PPAK 20/30 w/96 RHV RX Viatrac 14 Plus Peripheral Dilat RX Viatrac 14 Plus Peripheral Pacel™ Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773 Viatrac 14 Plus CoroFlow Cardiovascular System Omnilink Elite TAD II Guide Wire TAD Guide Wire Barewire Filter Delivery Wire Emboshield NAV6 Embolic Protection System JETi Non-sterile Canister Set StarClose SE Vascular Closure System Omnilink 35 Biliary Stent System Hi-Torque Powerturn Guide Wires Armada14 XT Dilatation Catheter Armada 18 PTA Catheter JETi Hydrodynamic Thrombectomy System Supera OPTIS Mobile Next Imaging System Ultreon 3 Software Upgrade Kit OPTIS Integrated Next Imaging System Hi-Torque JET Guide Wire Flexi-Wire Hi-Torque Extra S'port Viatrac 14 Plus Hi-Torque Whisper Guide Wires HI-TORQUE CROSS-IT 400XT GUIDE WIRE Trek RX Trek OTW Mini Trek II OTW (1.20 LTD IND Mini Trek OTW Dilatation Catheters Mini Trek RX Mini Trek II OTW (1.50-20) LOC Guidewire Extension Hi-Torque Versacore Standard Guide Wire Hi-Torque Versacore Floppy Guide Wire Hi-Torque Versacore Modified J Guide Wire Hi-Torque Versacore Guide Wire ILUMIEN OPTIS Mobile System ILUMIEN OPTIS Mobile System Accessories NC TREK NEO ProGlide Perclose AT Prostar XL 10 F Perclose ProStyle Suture-Mediated Closue and Repair System ECG Adapter Pacel Flow Directed Pacing Catheter Absolute Pro Vascular Self-Expanding Stent System Absolute Pro Self-Expanding Stent System Hi-Torque Balance Guide Wire Hi-Torque Pilot Guide Wire Hi-Torque Progress Guide Wire OPTIS Mobile System and Accessories Hi-Torque Balance Guide Wire Hi-Torque Balance Trek Guide Wire Hi-Torque Balance Middleweight Elite Guide Wire H-Torque Balance Middleweight Guide Wire Hi-Torque Balance Middleweight Universal Guide Wire Hi-Torque Balance HeavyWeight Guide Wire Hi-Torque Balance Meddleweight Universal II Guide Wire Hi-Torque Proceed Guide Wire HI-TORQUE Steelcore Bare Guide Wire Torque Device PTA 25-38 Torque Device (10 Pack) Guide Wire Accessory Kit with RHV Guide Wire Introducer Guide Wire Accessory Kit Torque Device; Guide Wire Introducer; Guide Wire Accessory Kit; Guide Wire Accessory Kit with RHV Accessory Kit with Bleedback Control Valve Torque Device OPTIS Mobile Next Optis Tableside Controller Next Optis Integrated Next Optis Mobile Next Imaging System Optis Integrated Pre-Install Kit Optis Mobile Next Direct Upgrade Accessory Kit Optis Next Upgrade Kit Ultreon 2 Software Upgrade Kit Hi-Torque Infiltrac Guide Wire Absolute Pro LL Self-Expanding Stent System ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter Dragonfly OPTIS Imaging Catheter Kit Hi-Torque Command 18 Disposable Patient Cables SJM Adapter Cable Connectors SJM™ Patient Cable 401758,401759,401760 SJM™ Threshold Cable 401748 SJM™ Epicardial Cable 401777, 401778 Abbott Medical Threshold Cable Abbott Medical Epicardial Cable Abbott Medical Patient Cable Hi-Torque Floppy II Guide Wire XPERT PRO Hi-Torque Floppy 18 OPTIS Integrated System and Accessories Armada 35 and 35LL Dilatation Catheters JETi Accessory Cart PressureWire X Hi-Torque Floppy II Extra Support Hi-Torque Winn Hi-Torque All Star Guide Wire Hi-Torque Command Guide Wire Absolute Pro 35 Biliary Self-Expanding Stent System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2007-11-27
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2026-03-12
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2012-12-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2021-02-05
NIN Stent, Renal Unknown Class 3 N/A 2012-09-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-01-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-06-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-09-03
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2022-04-29
MAF Stent, Coronary Unknown Class 3 N/A 2007-11-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-03
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2011-01-03
NIM Stent, Carotid Unknown Class 3 N/A 2008-11-04
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2018-06-22
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2018-06-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-06-28
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2018-06-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-11-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2007-11-27
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-06-22
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-06-22
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2014-05-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-27
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2004-06-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2023-04-26
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2019-04-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-04-02
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2020-10-21
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-10-21
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2011-01-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-03-01
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-04-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-11-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2006-05-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-27
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2007-03-01
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-11-27
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2021-02-05
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2008-11-04
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-05-02
OUG Medical Device Data System General Hospital Class 1 880.6310 2022-05-02
NIO Stent, Iliac Unknown Class 3 N/A 2012-08-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-12-15
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2019-08-23
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 1988-12-01
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2007-11-19
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2007-11-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-11-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-08-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-08-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2015-07-06
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2024-01-04
FOX Stand, Infusion General Hospital Class 1 880.6990 2024-01-04
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2024-01-04
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2014-04-09
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2026-05-13
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-05-13
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2026-05-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-01-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-27
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-01-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-05-19
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2011-01-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-12-15
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2022-07-07
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2007-12-03
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2007-12-11
NIO Stent, Iliac Unknown Class 3 N/A 2012-03-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-26
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-12-01
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-12-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-08-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-04-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-03-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-03-01
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2021-06-08
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2021-06-08
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-06-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-12-16
NIO Stent, Iliac Unknown Class 3 N/A 2016-06-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-05-18
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-08-28
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2007-12-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-03-01
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2014-10-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2011-10-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-10-17
FOX Stand, Infusion General Hospital Class 1 880.6990 1999-07-12
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2016-08-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-08-16
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2016-08-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2006-05-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-08-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-12-05
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28
K202800 Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Pacific Plus PTA Catheter 2020-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Similar Registrations

Registration Number Establishment Name Location
9681260 Boston Scientific Limited GALWAY, IE
3008132398 Sterigenics UK Limited Alfreton Derbyshire, GB
2124215 Boston Scientific Corporation Saint Paul, MN, US
3004091615 Abbott Vascular Netherlands Heerlen Limburg, NL
1000121056 Boston Scientific Corporation Coventry, RI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024168. Last updated year: 2026. Please use registration number 2024168 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.