FDA Registration Active 🇺🇸 United States

ABBOTT VASCULAR

Reg #: 2939561 · FEI: 3004635528 · Expires 2026
Products
24
Proprietary Names
127
Establishment Types
1
Classifications
24

Registration Details

Registration Name
ABBOTT VASCULAR
Registration Number
2939561
FEI Number
3004635528
Status
Active
Expiry Year
2026
Initial Importer
No
Address
3200 Lakeside Dr
City
SANTA CLARA
State
CA
ZIP
95054
Country
US

Regulatory Submissions

510(k) Number
K963702
PMA Number
P040012

Owner / Operator

Firm Name
ABBOTT LABORATORIES
Operator Number
1415939
Address
100 ABBOTT PARK RD., D-03Q3, AP52-1
City
Abbott Park
State
IL
Postal Code
60064
Country
US

Products

Device Name Product Code
Wire, Guide, Catheter DQX
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
Catheter, Percutaneous DQY
Catheter, Angioplasty, Peripheral, Transluminal LIT
Catheter, Steerable DRA
Stent, Carotid NIM
Stent, Iliac NIO
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Coronary Drug-Eluting Stent NIQ
Scaffold, Infrapopliteal, Absorbable NXW
Catheter, Flow Directed DYG
Coronary Covered Stent NIV
Stent, Coronary MAF
Electrode, Pacemaker, Temporary LDF
Mitral Valve Repair Devices NKM
Temporary Carotid Catheter For Embolic Capture NTE
Stent, Superficial Femoral Artery NIP
Device, Hemostasis, Vascular MGB
Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
Stents, Drains And Dilators For The Biliary Ducts FGE
Stent, Renal NIN
Introducer, Catheter DYB
Syringe, Balloon Inflation MAV

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 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 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 Hi-Torque Traverse Guide Wire 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 Absolute Pro 35 Biliary Self-Expanding Stent System HT Command 14 ST HT Command 14 MT Hi-Torque Command Guide Wire Hi-Torque Flex-T Guide Wire StarClose SE Vascular Closure System NC TREK RX CORONARY DILATATION CATHETER Hi-Torque VersaTurn Flex Guide Wire Hi-Torque VersaTurn Ultraflex Guide Wire Hi-Torque VersaTurn Guide Wire Armada 18 PTA Catheter Hi-Torque Floppy 18 HI-TORQUE CROSS-IT 400XT GUIDE WIRE Hi-Torque Supra Core Guide Wire Rotating Hemostatic Valve (.115) PPAK 20/30 w/.115 RHV 20/30 Indeflator 20/30 PPAK with Bleedback Control Valve PPAK 20/30 w/96 RHV Hi-Torque Cross-It XT Hi-Torque Winn

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility