Data / Medical devices / Netherlands / Abbott Vascular Netherlands
Abbott Vascular Netherlands: FDA-registered device maker in Heerlen Limburg, Netherlands, 90 510(k) clearances and 12 PMA approvals
Abbott Vascular Netherlands is registered with the FDA (registration 3004091615) in Heerlen Limburg, Netherlands. It lists 35 device types. The FDA files 90 510(k) clearances and 12 PMA approvals under its listings, the newest dated April 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004091615
- Address
- Argonstraat 1, Heerlen Limburg, Netherlands, 6422 PH
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Exporter to the US
- First device listed
- June 23, 2004
- Registered through
- 2026
- Brand names listed
- 20 Max Crown, 20/30 Indeflator, 20/30 PPAK w/COPILOT, 20/30 PPAK with Bleedback Control Valve, AMPLATZER Guidewires, AMPLATZER Vascular Plug - II ES, AMPLATZER Vascular Plug 4, Abbott Medical Epicardial Cable and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 30, 2022 | K220634 | NC TREK NEO Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| May 5, 2022 | K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| April 30, 2022 | K220243 | Ultiri Measurement System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 27, 2022 | K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | MCW | Substantially Equivalent | Cardiovascualr Systems, Inc. | accessdata.fda.gov |
| February 1, 2022 | K213565 | JETi AIO Peripheral Thrombectomy System | QEZ | Substantially Equivalent | Walk Vascular, LLC | accessdata.fda.gov |
| September 14, 2021 | K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| August 26, 2021 | K211240 | ViperCross Support Catheters | DQY | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 3, 2021 | K210282 | WIRION Embolic Protection System | NTE | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| November 19, 2020 | K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| November 13, 2020 | K201881 | CoroFlow Cardiovascular System | DQK | Substantially Equivalent | Coroventis Research AB | accessdata.fda.gov |
| July 30, 2020 | K201834 | HI-TORQUE PROCEED Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| March 18, 2020 | K200198 | WIRION | NTE | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 17, 2019 | K192267 | ILUMIEN System with AptiVue Software version D.3 | DQO | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 11, 2019 | K193126 | HI-TORQUE InfilTrac Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| July 25, 2019 | K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | NTE | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| July 2, 2019 | K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 29, 2018 | K183000 | ViperCath XC Peripheral Exchange Catheter | DQY | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 13, 2018 | K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| August 24, 2018 | K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| April 17, 2018 | K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 28, 2018 | K180558 | PressureWire X | DXO | Substantially Equivalent | St. Jude Medical (Now Part of Abbott Medical) | accessdata.fda.gov |
| January 12, 2018 | K173795 | HI-TORQUE TurnTrac Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 25, 2017 | K172073 | Hi-Torque Command 18 Guide Wire | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| June 9, 2017 | K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| October 21, 2015 | K152709 | HI-TORQUE BALANCE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| October 21, 2015 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| July 6, 2015 | K151317 | Armada 18 PTA Catheter | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| June 10, 2015 | K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD | MCW | Substantially Equivalent | Cardiovascular System, Inc. | accessdata.fda.gov |
| May 5, 2015 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| April 13, 2015 | K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 17, 2014 | K140536 | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Medical | accessdata.fda.gov |
| August 7, 2014 | K141782 | HI-TORQUE VERSATURN GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| March 11, 2014 | K140327 | ULTIMUM EV HEMOSTASIS INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| February 28, 2014 | K133999 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| November 22, 2013 | K133399 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems Incorporated | accessdata.fda.gov |
| January 30, 2013 | K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| January 29, 2013 | K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| November 20, 2012 | K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| August 15, 2012 | K121352 | ARMADA 14XXT PTA CATHETER | DQY | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| June 12, 2012 | K113658 | AMPLATZER VASCULAR PLUG 4 | KRD | Substantially Equivalent | Aga Medical Corp. | accessdata.fda.gov |
| March 6, 2012 | K113464 | NC TREK OTW CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| November 8, 2011 | K112957 | HI-TORQUE POWERTURN | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| November 3, 2011 | K112381 | HI TORQUE CONNECT GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Medical | accessdata.fda.gov |
| October 3, 2011 | K111899 | ARMADA 35/35LL PTA CATHETER | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| July 26, 2011 | K111388 | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| June 9, 2011 | K111092 | ENGAGE/ENGAGE TR INTRODUCERS | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 11, 2011 | K110389 | STEALTH 360 ORBITAL PAD SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| February 11, 2011 | K110134 | NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| February 10, 2011 | K103101 | HI-TORQUE BALANCE MIDDLEWEIGHT ELITE | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| January 10, 2011 | K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| December 30, 2010 | K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| December 7, 2010 | K102705 | ARMADA 14 PTA CATHETER | LIT | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| July 8, 2010 | K101648 | HI-TORQUE WINN GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| June 23, 2010 | K101116 | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| April 22, 2009 | K091137 | ULTIMUM/ENGAGE/ENGAGE TR | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 11, 2009 | K083738 | HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| February 25, 2009 | K083732 | TAD AND TAD II TAPERED GUIDE WIRES | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| February 6, 2009 | K083706 | HI-TORQUE VERSACORE GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 18, 2008 | K072708 | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM | FGE | Unknown | Abbott Vascular-Vascular Solutions | accessdata.fda.gov |
| April 11, 2008 | K072460 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| August 15, 2007 | K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 | KRD | Substantially Equivalent | Aga Medical Corp. | accessdata.fda.gov |
| June 18, 2007 | K071125 | AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 | KRD | Substantially Equivalent | Aga Medical Corp. | accessdata.fda.gov |
| March 6, 2006 | K053454 | RX HERCULINK ELITE BILIARY STENT SYSTEM | FGE | Unknown | Guidant Corporation | accessdata.fda.gov |
| September 9, 2003 | K031810 | AMPLATZER VASCULAR PLUG | KRD | Substantially Equivalent | Aga Medical Corp. | accessdata.fda.gov |
| October 31, 2002 | K023447 | MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| January 3, 2001 | K003729 | ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 1, 2000 | K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| October 28, 1999 | K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991102 | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 | DTL | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 25, 1999 | K990639 | ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 8, 1999 | K984394 | ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| November 10, 1998 | K982876 | HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 20, 1998 | K980119 | ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| August 25, 1997 | K972142 | ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| January 22, 1997 | K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| May 8, 1996 | K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | MAV | Unknown | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| May 15, 1995 | K950752 | ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| April 13, 1994 | K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE | DYB | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| December 16, 1993 | K934602 | ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 9, 1993 | K934339 | LOC GUIDE WIRE EXTENSION | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| January 27, 1992 | K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER | LDF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| December 13, 1991 | K914138 | ONTRAC | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| October 28, 1991 | K913631 | .014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| October 23, 1991 | K913353 | VASCULAR GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| May 7, 1991 | K910645 | DISPOSABLE PATIENT CABLE | DSA | Substantially Equivalent | Diag Corp. | accessdata.fda.gov |
| September 26, 1989 | K894343 | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO | DYB | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| August 3, 1988 | K881897 | ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| February 12, 1988 | K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE | LDF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| December 4, 1985 | K854261 | ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES | DTL | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 26, 2024 | P230036 | Esprit BTK Everolimus Eluting Resorbable Scaffold System | NXW | 19 | September 24, 2026 | accessdata.fda.gov |
| March 28, 2014 | P120020 | SUPERA PERIPHERAL STENT SYSTEM | NIP | 36 | March 20, 2026 | accessdata.fda.gov |
| October 24, 2013 | P100009 | MITRACLIP DELIVERY SYSTEM | NKM | 82 | June 25, 2026 | accessdata.fda.gov |
| October 21, 2013 | P130005 | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM | MCX | 49 | March 10, 2026 | accessdata.fda.gov |
| July 31, 2012 | P110043 | OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM | NIO | 14 | January 12, 2026 | accessdata.fda.gov |
| February 22, 2012 | P110028 | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM | NIO | 25 | October 22, 2025 | accessdata.fda.gov |
| November 1, 2011 | P110019 | Xience Skypoint Everolimus Eluting Coronary Stent System | NIQ | 134 | October 1, 2026 | accessdata.fda.gov |
| July 20, 2011 | P110001 | RX HERCULINK ELITE RENAL STENT SYSTEM | NIN | 21 | October 22, 2025 | accessdata.fda.gov |
| December 21, 2005 | P050007 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | 49 | April 17, 2026 | accessdata.fda.gov |
| September 6, 2005 | P040038 | XACT CAROTID STENT SYSTEM | NIM | 48 | March 20, 2026 | accessdata.fda.gov |
| August 30, 2004 | P040012 | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM | NIM | 64 | October 22, 2025 | accessdata.fda.gov |
| April 30, 1997 | P960043 | PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM | MGB | 131 | September 24, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Catheter, Percutaneous
- All makers of Stent, Renal
- All makers of Wire, Guide, Catheter
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.