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
Phone
951 9143324

Products

Device Name Product Code
Wire, Guide, Catheter DQX
Syringe, Balloon Inflation MAV
Catheter, Peripheral, Atherectomy MCW
Catheter, Flow Directed DYG
Coronary Covered Stent NIV
Stent, Coronary MAF
Coronary Drug-Eluting Stent NIQ
Stents, Drains And Dilators For The Biliary Ducts FGE
System, Imaging, Optical Coherence Tomography (Oct) NQQ
Catheter, Intravascular, Diagnostic DQO
Catheter, Coronary, Atherectomy MCX
Device, Hemostasis, Vascular MGB
Catheter, Angioplasty, Peripheral, Transluminal LIT
Stent, Carotid NIM
Device, Vascular, For Promoting Embolization KRD
Introducer, Catheter DYB
Electrode, Pacemaker, Temporary LDF
Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
Tape, Measuring, Rulers And Calipers FTY
Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
Transducer, Pressure, Catheter Tip DXO
Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
Temporary Carotid Catheter For Embolic Capture NTE
Catheter, Percutaneous DQY
Scaffold, Infrapopliteal, Absorbable NXW
Mitral Valve Repair Devices NKM
Stent, Superficial Femoral Artery NIP
Stent, Renal NIN
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Stent, Iliac NIO
Computer, Diagnostic, Programmable DQK
Computer, Blood-Pressure DSK
Medical Device Data System OUG
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Aspiration Thrombectomy Catheter QEZ

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