# Stryker Neurovascular

- Location (FDA's records): Fremont, CA
- FDA decisions: 36 (2011–2026): 34 510(k) clearances and 2 original PMA approvals
- Product codes: HCG (11), QJP (10), DQY (6), POL (3), NRY (2), MJN (1), MOF (1), OUT (1), QCA (1)
- 510(k) review time since 2016: median 114 days, against 111 for FDA's reviews in the same codes and years (10 of 25 faster)
- Predicates its devices cite: 44 (20 its own); citations of its devices by later devices: 39 (20 its own)
- Recalls linked to its devices: 46 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 9 (https://510kreport.com/company/boston-scientific)
- Stryker Corp.: 6 (https://510kreport.com/company/stryker)
- Inneuroco, Inc.: 2 (https://510kreport.com/company/inneuroco)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Boston Scientific, Target: 1 (https://510kreport.com/company/boston-scientific-target)
- Boston Scientific Scimed, Inc.: 1 (https://510kreport.com/company/boston-scientific-scimed)
- Stryker Neurovscular: 1 (https://510kreport.com/company/stryker-neurovscular)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)

## Firms that cite its devices most
- Stryker Neurovscular: 4 (https://510kreport.com/company/stryker-neurovscular)
- Sequent Medical, Inc.: 2 (https://510kreport.com/company/sequent-medical)
- Kaneka Pharma America, LLC: 2 (https://510kreport.com/company/kaneka-pharma-america)
- MicroPort NeuroTech (Shanghai) Co., Ltd.: 2 (https://510kreport.com/company/microport-neurotech-shanghai)
- Arbor Endovascular, LLC: 1 (https://510kreport.com/company/arbor-endovascular)
- Cerenovus, Inc.: 1 (https://510kreport.com/company/cerenovus)
- Route 92 Medical, Inc.: 1 (https://510kreport.com/company/route-92-medical)
- Reverse Medical Corporation: 1 (https://510kreport.com/company/reverse-medical)

## Its most-cited devices
- K161429: Target Detachable Coils (2016), cited by 4
- K113778: Excelsior XT-27 Microcatheter (2012), cited by 4
- K160096: InZone Detachment System (2016), cited by 3
- K153658: Target Detachable Coils (2016), cited by 3
- K112385: Traget Detachable Coil (2011), cited by 3
- K190833: AXS Vecta Aspiration Catheter (2019), cited by 2

## Recent decisions
- K261649: Excelsior Reach Microcatheter (Oct 9, 2026)
- K261889: Trevo Trak 21 Microcatheter (Jul 1, 2026)
- K253032: AXS Lift Intracranial Base Catheter (Feb 11, 2026)
- K252694: Target Detachable Coil (Dec 11, 2025)
- K251832: InZone IST Detachment System; IZDS Connecting Cable (Oct 17, 2025)
- K242289: Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (Mar 21, 2025)
- K243593: AXS Lift Intracranial Base Catheter (Feb 18, 2025)
- K241637: Echo Intracranial Base Catheter (Dec 19, 2024)

Source page: https://510kreport.com/company/stryker-neurovascular