Stryker Neurovascular

FDA Device Registration & Listing · Cork Munster, IE · Registration 3008881809

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008881809
FEI Number
3008881809
Entity Name
Stryker Neurovascular
City/State/Country
Cork Munster, IE
Establishment Address
Business and Technology Park, Model Farm Road, Cork Munster 00000, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P170024

All Registered Proprietary Names

AXS Catalyst 6 AXS Catalyst 5 Excelsior® XT-27® Microcatheters Target Tetra Detachable Coils Excelsior XT-27 Microcatheter Excelsior SL-10 Microcatheter Neuroform EZ Stent System AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter) AXS Catalyst Distal Access Catheter Target XXL 360 Excelsior XT-17 Microcatheter Excelsior XT-17 Flex Microcatheter Target Detachable Coils AXS Offset Delivery Assist Catheter Excelsior 1018 Microcatheter Neuroform Atlas Stent System Excelsior 1018 Pre-Shaped Microcatheter Excelsior SL-10 Pre-Shaped Microcatheter TransForm Super Compliant Occlusion Balloon Catheter TransForm Compliant Occlusion Balloon Catheter Target 360 Standard Target Helical Nano Target 360 Soft Target XL Helical Target Helical Ultra Target XL 360 Soft Target 360 Nano Target 360 Ultra Target XL 360 Standard Target 3D Gateway PTA Balloon Catheter Wingspan Stent System Surpass Streamline Flow Diverter Surpass Evolve Flow Diverter Surpass Elite Flow Diverter System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-11-18
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-22
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-08-22
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-12-15
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2022-12-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-04-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-04-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2012-04-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-31
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2011-04-01
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-03-14
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-04-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-04-16
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2016-12-08
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2016-12-08
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-21
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2025-01-21
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2025-01-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-11-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2011-01-31
QCA Intracranial Coil-Assist Stent Unknown Class 3 N/A 2019-05-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-31
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2013-01-24
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-08-25
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-08-25
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2011-04-01
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2018-08-02

Official Correspondent

No official correspondent registered.

US Agent Details

Breskella Halteh Business: STRYKER Neurovascular Email: breskella.halteh@stryker.com Phone: (650) 8143781

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19
K082339 Endocross, Ltd. ENABLER-P SUPPORT CATHETER 2008-11-20
K210009 CenterPoint Systems, LLC Guiding Catheter 2021-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2025 Stryker Neurovascular 2
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008881809. Last updated year: 2026. Please use registration number 3008881809 when referencing this establishment in official correspondence.
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