Data / Medical devices / Ireland / Stryker Neurovascular
Stryker Neurovascular: FDA-registered device maker in Cork Munster, Ireland, 21 510(k) clearances and 2 PMA approvals
Stryker Neurovascular is registered with the FDA (registration 3008881809) in Cork Munster, Ireland. It lists 10 device types. The FDA files 21 510(k) clearances and 2 PMA approvals under its listings, the newest dated October 9, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008881809
- Address
- Business and Technology Park Model Farm Road, Cork Munster, Ireland, 00000
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer
- First device listed
- January 31, 2011
- Registered through
- 2027
- Brand names listed
- AXS Catalyst 5, AXS Catalyst 6, AXS Catalyst Distal Access Catheter, AXS Catalyst Distal Access Catheter (AXS Catalyst 7), AXS Offset Delivery Assist Catheter, AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter), Excelsior 1018 Microcatheter, Excelsior 1018 Pre-Shaped Microcatheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Thrombus Retriever | NRY | 2 | Manufacturer | accessdata.fda.gov |
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
| Intracranial Aneurysm Flow Diverter | OUT | 3 | Manufacturer | accessdata.fda.gov |
| Intracranial Coil-Assist Stent | QCA | 3 | Manufacturer | accessdata.fda.gov |
| Intracranial Neurovascular Stent | NJE | f | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| October 9, 2026 | K261649 | Excelsior Reach Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| June 24, 2026 | K261772 | Target Xtra Detachable Coil | HCG | Substantially Equivalent | Stryker Neurovscular | accessdata.fda.gov |
| December 11, 2025 | K252694 | Target Detachable Coil | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| March 21, 2025 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| August 29, 2024 | K242243 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovscular | accessdata.fda.gov |
| December 14, 2022 | K222533 | Target Tetra Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| March 13, 2019 | K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | NRY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 13, 2019 | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | DQY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 18, 2018 | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm | NRY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| July 28, 2017 | K163259 | AXS Offset Delivery Assist Catheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| June 22, 2016 | K161429 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| May 19, 2016 | K153658 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| January 8, 2016 | K152876 | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM | DQY | Substantially Equivalent | Tni Manufacturing, Inc. | accessdata.fda.gov |
| November 13, 2015 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm | DQY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| November 14, 2014 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| January 11, 2013 | K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT | MJN | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 30, 2012 | K123377 | TARGET DETACHABLE COIL | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| April 20, 2012 | K113778 | EXCELSIOR XT-27 MICROCATHETER | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| October 15, 2004 | K042568 | EXCELSIOR 1018 AND SL-10 MICROCATHETERS | DQY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| December 6, 2001 | K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | DQY | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| August 3, 2000 | K994155 | EXCELSIOR 1018 MICROCATHETER | KRA | Substantially Equivalent | Boston Scientific, Target | 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 |
|---|---|---|---|---|---|---|
| May 16, 2019 | P180031 | Neuroform Atlas® Stent System | QCA | 12 | October 24, 2026 | accessdata.fda.gov |
| July 13, 2018 | P170024 | Surpass Streamline Flow Diverter | OUT | 26 | August 28, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Neurovascular Embolization
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Catheter, Percutaneous
- All makers of Catheter, Continuous Flush
- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Intracranial Neurovascular Stent
Updated October 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.