Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004091615

FEI Number

3004091615

Entity Name

Abbott Vascular Netherlands

City/State/Country

Heerlen Limburg, NL

Establishment Address

Argonstraat 1, Heerlen Limburg 6422 PH, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K881897

PMA Number

N/A

All Registered 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 Peripheral Micro 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 DIAMONDBACK 360 Peripheral Orbital Atherectomy System 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2007-03-01
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-31
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-11-26
NIV	Coronary Covered Stent	Unknown	Class f	N/A	2007-11-26
MAF	Stent, Coronary	Unknown	Class 3	N/A	2007-11-26
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-07-14
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2011-11-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2007-11-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-08-17
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2020-10-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2020-10-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-12-05
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-11-04
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2013-10-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2007-12-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-12-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-07-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
NIM	Stent, Carotid	Unknown	Class 3	N/A	2008-11-04
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-31
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-12-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-08-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-08-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-12-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-24
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2018-06-15
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2007-12-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2011-01-12
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-06-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2008-09-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-09-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-01-18
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-30
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	Class 1	870.3955	2024-11-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-30
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2012-12-06
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-12-04
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2018-06-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-06-28
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2018-06-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-07-20
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2020-04-03
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2020-12-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-01-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-12-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2011-11-29
NXW	Scaffold, Infrapopliteal, Absorbable	Unknown	Class 3	N/A	2024-04-29
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2013-11-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-05-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-11-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-12-16
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2011-10-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-10-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-05-18
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2017-05-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-07-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-06-10
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2019-08-23
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2014-04-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-27
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-04-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2006-05-23
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-01-11
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-12-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-07-20
NIN	Stent, Renal	Unknown	Class 3	N/A	2012-09-07
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-12-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-03-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2006-05-23
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-03-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-12-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-03-01

Official Correspondent

No official correspondent registered.

US Agent Details

Keith Krohn Business: Abbott Vascular Email: keith.krohn@abbott.com Phone: (951) 9143324

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004091615. Last updated year: 2026. Please use registration number 3004091615 when referencing this establishment in official correspondence.