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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-11-27 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2011-01-12 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2011-01-03 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2011-01-03 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2019-07-17 |
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2005-08-01 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2012-08-01 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2014-05-08 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2011-11-01 |
| Scaffold, Infrapopliteal, Absorbable | NXW | Class 3 | Unknown | No | 2024-04-29 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2007-11-26 |
| Coronary Covered Stent | NIV | Class f | Unknown | No | 2007-11-26 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2007-11-26 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2021-02-05 |
| Mitral Valve Repair Devices | NKM | Class 3 | Unknown | No | 2013-11-22 |
| Temporary Carotid Catheter For Embolic Capture | NTE | Class 2 | Cardiovascular | No | 2019-08-23 |
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2014-04-09 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2007-12-03 |
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2024-11-14 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Stent, Renal | NIN | Class 3 | Unknown | No | 2012-09-07 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-03-01 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2007-03-01 |
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