FDA Registration
Active
🇳🇱 Netherlands
Abbott Vascular Netherlands
Reg #: 3004091615
·
FEI: 3004091615
·
Expires 2026
Products
35
Proprietary Names
166
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- Abbott Vascular Netherlands
- Registration Number
- 3004091615
- FEI Number
- 3004091615
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Argonstraat 1
- City
- Heerlen Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K984394
- PMA Number
- H000001
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
US Agent
- Business Name
- Abbott Vascular
- Contact Name
- Keith Krohn
- Address
- 26531 Ynez Road, M/S TCC-215
- City
- Temecula
- State
- CA
- ZIP
- 92591
- Country
- US
- [email protected]
- Phone
- 951 9143324
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-11-30 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2007-03-01 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2014-10-31 |
| 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 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2011-11-01 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2020-10-21 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2020-10-21 |
| Catheter, Coronary, Atherectomy | MCX | Class 3 | Unknown | No | 2013-10-28 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2007-12-03 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2015-07-06 |
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2008-11-04 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2017-02-17 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2009-08-20 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2007-12-11 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2011-01-12 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2008-09-19 |
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2024-11-14 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2018-06-28 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2018-06-28 |
| Temporary Carotid Catheter For Embolic Capture | NTE | Class 2 | Cardiovascular | No | 2020-04-03 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2019-01-03 |
| Scaffold, Infrapopliteal, Absorbable | NXW | Class 3 | Unknown | No | 2024-04-29 |
| Mitral Valve Repair Devices | NKM | Class 3 | Unknown | No | 2013-11-22 |
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2014-04-09 |
| Stent, Renal | NIN | Class 3 | Unknown | No | 2012-09-07 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2012-03-07 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-06-22 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-06-22 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2022-05-02 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2007-03-01 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2022-04-29 |
Proprietary Names
Hi-Torque Wiggle Guide Wire
PPAK 20/30 w/.115 RHV
20/30 Indeflator
20/30 PPAK with Bleedback Control Valve
PPAK 20/30 w/96 RHV
Diamondback Peripheral Micro
Graftmaster
Graftmaster RX
20 Max Crown
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
RX Herculink Elite Biliary Stent Sy
Hi-Torque Proceed Guide Wire
ILUMIEN Systems with AptiVue Software Version D.3
HydroSteer
Absolute Pro 35 Biliary Self-Expanding Stent System
DIAMONDBACK 360 Coronary Orbital Atherectomy System
LOC Guidewire Extension
ProGlide
Perclose AT
Prostar XL 10 F
Perclose ProStyle Suture-Mediated Closue and Repair System
Hi-Torque Pilot Guide Wire
Hi-Torque Progress Guide Wire
Armada 18 PTA Catheter
Hi-Torque Supra Core Guide Wire
X.act Carotid Stent System
Xact Carotid Stent System
XACT Transcarotid Stent System
DIAMONDBACK 360 Peripheral Orbital Atherectomy System
Amplatzer Vascular Plug (AVP)
Amplatzer Vascular Plug
Hi-Torque Command 18
Hi-Torque Winn
Hi-Torque Flex-T Guide Wire
Percutaneous Catheter Introducer & Removable Hemo
Hemostasis Valve Adapter
Fast-Cath Hemostasis Introducer
Hi-Torque Connect
Viperwire Advance with Flextip
ECG Adapter
Pacel Flow Directed Pacing Catheter
NC TREK RX Coronary Dilatation Catheter
NC TREK RX CORONARY DILATATION CATHETER
ViperTrack
Hi-Torque VersaTurn Flex Guide Wire
Hi-Torque VersaTurn Ultraflex Guide Wire
Hi-Torque VersaTurn Guide Wire
Hi-Torque TurnTrac Guide Wires
Stealth OAS
Diamondback OAS
MitraClip and TriClip Accessories Plate
MitraClip and TriClip Accessories Stabilizer
MitraClip and TriClip Accessories Lift
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Pacel Bipolar Pacing Catheter
PressureWire X
Ultimum EV Hemostasis Introducer
WIRION
DiamondBack 360 Peripheral Orbital Atherectomy System, Exchangeable
Stealth 360 Peripheral Orbital Atherectomy System
DiamondBack 360 Peripheral Orbital Atherectomy System
ViperCath XC Peripheral Exchange Catheter
Hi-Torque Iron Man
Spartacore Guide Wire
Hi-Torque Iron Man Guide Wire W/Mic
Hi-Torque Command Guide Wire
Hi-Torque Powerturn Guide Wires
Stealth 360 PAD System
Esprit BTK Everolimus Eluting Resorbable Scaffold System
MitraClip Clip Delivery System
MitraClip G4 System
MitraClip G5 Delivery system
Hi-Torque Whisper Guide Wires
Hi-Torque BMW Universal II Guide Wire
Hi-Torque BMW Universal II
Hi-Torque Infiltrac Guide Wire
Armada 35 and 35LL Dilatation Catheters
ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter
Dragonfly OPTIS Imaging Catheter Kit
Engage Introducer
Engage TR Introducer
Hi-Torque All Star Guide Wire
Hi-Torque BMW Elite Guide Wire
Barewire Filter Delivery Wire
Emboshield NAV6 Embolic Protection System
Supera
Hi-Torque Cross-It XT
NC TREK OTW CORONARY DILATATION CATHETER
Hi-Torque Traverse Guide Wire
Viatrac 14 Plus
Diamondback 360® Peripheral Orbital Atherectomy
AMPLATZER Guidewires
GuideRight GuideWires
RX Herculink Elite Renal Stent System
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
Amplatzer Vascular Plug II (AVP II)
Ultimum
Ultimum Introducer
Hi-Torque Floppy II Extra Support
Absolute Pro Vascular Self-Expanding Stent System
Absolute Pro Self-Expanding Stent System
TAD II Guide Wire
TAD Guide Wire
Hi-Torque Floppy II Guide Wire
Ultiri Measurement System
ViperCross Support Catheters
Omnilink Elite
TigerWire GuideWires
HI-TORQUE CROSS-IT 400XT GUIDE WIRE
VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire
StarClose SE Vascular Closure System
WIRION Embolic Protection System
CoroFlow Cardiovascular System
Armada14 XT Dilatation Catheter
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)
ViperSlide Lubricant
NC TREK NEO
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
Diamondback
Hi-Torque Versacore Standard Guide Wire
Hi-Torque Versacore Floppy Guide Wire
Hi-Torque Versacore Modified J Guide Wire
Hi-Torque Versacore Guide Wire
Rotating Hemostatic Valve (.115)
Armada 14 PTA Catheter
Guide Wire Accessory Kit with Copilot
20/30 PPAK w/COPILOT
COPILOT BBC Valve
AMPLATZER Vascular Plug 4
AMPLATZER Vascular Plug - II ES
Hi-Torque Floppy 18
JETi Hydrodynamic Thrombectomy System
GuideRight Guidewires
Rotating Hemostatic Valve
RX ACCULINK CAROTID STENT SYSTEM
Mini Trek OTW
Mini Trek II OTW
Hi-Torque Connect Guide Wire
Hi-Torque Steelcore Guide Wire
Hi-Torque Steelcore 18 Guide Wire
Trek RX; Mini Trek RX (1.50-20 Global);
Mini Trek RX (1.20 LTD IND);
Establishment Types
Export Device to the United States But Perform No Other Operation on Device