Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2939561

FEI Number

3004635528

Entity Name

ABBOTT VASCULAR

City/State/Country

SANTA CLARA, CA, US

Establishment Address

3200 Lakeside Dr, SANTA CLARA, CA 95054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

Expiration Date (Year)

2026

510(k) Number

K103153

PMA Number

N/A

All Registered Proprietary Names

Hi-Torque Iron Man Spartacore Guide Wire Hi-Torque Iron Man Guide Wire W/Mic 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 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) Armada 14 PTA Catheter Steerable Guide Catheter RX ACCULINK CAROTID STENT SYSTEM Hi-Torque Command 18 Omnilink Elite Armada 14 NC PTA Catheter Hi-Torque Floppy II Extra Support Steerable Guide Catheter Hi-Torque Powerturn Guide Wires Rotating Hemostatic Valve HI-TORQUE Steelcore Bare Guide Wire Hi-Torque Proceed Guide Wire Viatrac 14 Plus XIENCE Alpine Everolimus Eluting Stent System XIENCE Xpedition Everolimus Eluting Stent System XIENCE Sierra Everolimus Eluting Stent System XIENCE Skypoint Everolimus Eluting Stent System XIENCE PRIME Everolimus Eluting Stent System XIENCE ProS Everolimus Eluting Stent System Esprit BTK Everolimus Eluting Resorbable Scaffold System Hi-Torque Pilot Guide Wire Hi-Torque Progress Guide Wire Graftmaster Graftmaster RX Hi-Torque BMW Universal II Guide Wire Hi-Torque BMW Universal II Hi-Torque Infiltrac Guide Wire Hi-Torque TurnTrac Guide Wires Mini Trek OTW Mini Trek RX Mini Trek II OTW Trek RX; Mini Trek RX (1.50-20 Global); Mini Trek RX (1.20 LTD IND); Guide Wire Accessory Kit with Copilot 20/30 PPAK w/COPILOT COPILOT BBC Valve Armada 35 and 35LL Dilatation Catheters Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764 Hi-Torque Floppy II Guide Wire MitraClip Clip Delivery System MitraClip G4 System MitraClip G5 Delivery system Hi-Torque Versacore Standard Guide Wire Hi-Torque Versacore Floppy Guide Wire Hi-Torque Versacore Modified J Guide Wire Hi-Torque Versacore Guide Wire Barewire Filter Delivery Wire Emboshield NAV6 Embolic Protection System Hi-Torque Whisper Guide Wires X.act Carotid Stent System Xact Carotid Stent System XACT Transcarotid Stent System Hi-Torque Wiggle Guide Wire Hi-Torque Floppy II w/ Hydrocoat Hi-Torque Floppy II Extra Support w/ Hydrocoat NC TREK OTW CORONARY DILATATION CATHETER Supera Pacel Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773 ProGlide Perclose AT Prostar XL 10 F Perclose ProStyle Suture-Mediated Closue and Repair System DOC Guide Wire Extension MitraClip and TriClip Accessories Plate MitraClip and TriClip Accessories Stabilizer MitraClip and TriClip Accessories Lift RX Herculink Elite Biliary Stent Sy LOC Guidewire Extension RX Herculink Elite Renal Stent System Hi-Torque Extra S'Port Guide Wire Hi-Torque Flexi-Wire Guide Wire Hi-Torque All Star Guide Wire TAD II Guide Wire TAD Guide Wire Hi-Torque BMW Elite Guide Wire Armada14 XT Dilatation Catheter Absolute Pro Vascular Self-Expanding Stent System Absolute Pro Self-Expanding Stent System Hi-Torque Steelcore Guide Wire Hi-Torque Steelcore 18 Guide Wire NC TREK NEO NC TREK RX Coronary Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-12-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2011-01-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-01-03
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2011-01-03
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2019-07-17
NIM	Stent, Carotid	Unknown	Class 3	N/A	2005-08-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-08-28
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-08-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2026-03-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2006-05-23
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2019-07-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-14
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2014-05-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-04-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-08-17
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-01-11
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2011-11-01
NXW	Scaffold, Infrapopliteal, Absorbable	Unknown	Class 3	N/A	2024-04-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-12-01
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-11-26
NIV	Coronary Covered Stent	Unknown	Class f	N/A	2007-11-26
MAF	Stent, Coronary	Unknown	Class 3	N/A	2007-11-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-11-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-01-18
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-06-22
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2019-12-06
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2007-03-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2011-10-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-10-17
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2021-02-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-03-01
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2013-11-22
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
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-05-19
NIM	Stent, Carotid	Unknown	Class 3	N/A	2008-11-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-04-16
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2014-04-09
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2021-02-05
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2007-12-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	Class 1	870.3955	2024-11-14
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	2007-11-30
NIN	Stent, Renal	Unknown	Class 3	N/A	2012-09-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-12-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-06-10
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-08-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-08-16
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-03-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2004-06-23
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2022-07-07
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2011-01-12

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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

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-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2939561. Last updated year: 2026. Please use registration number 2939561 when referencing this establishment in official correspondence.