Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Neurovascular — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
231 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026-07-01 | 26 | 0 |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 | 142 | 0 |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 2025-12-11 | 107 | 0 |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | 2025-10-17 | 123 | 0 |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcat | Stryker Neurovascular | 2025-03-21 | 231 | 0 |
| K243593 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2025-02-18 | 90 | 0 |
| K241768 | Broadway 8 Catheter | Stryker Neurovascular | 2024-12-19 | 182 | 0 |
| K241637 | Echo Intracranial Base Catheter | Stryker Neurovascular | 2024-12-19 | 195 | 0 |
| K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2023-03-29 | 153 | 1 |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022-12-14 | 114 | 0 |
| K211594 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2021-11-26 | 186 | 3 |
| K212455 | InZone Detachment System | Stryker Neurovascular | 2021-11-16 | 103 | 1 |
| K202752 | AXS Vecta 46 Intermediate Catheter | Stryker Neurovascular | 2021-08-27 | 340 | 0 |
| K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021-08-27 | 186 | 0 |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020-12-29 | 57 | 0 |
| K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020-09-25 | 24 | 1 |
| K200206 | AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediat | Stryker Neurovascular | 2020-02-27 | 30 | 0 |
| K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | 2019-12-15 | 258 | 0 |
| K193034 | AXS Infinity LS Plus Long Sheath | Stryker Neurovascular | 2019-11-29 | 29 | 0 |
| K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019-07-30 | 29 | 0 |
| K190212 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019-04-24 | 79 | 0 |
| K163259 | AXS Offset Delivery Assist Catheter | Stryker Neurovascular | 2017-07-28 | 249 | 0 |
| K161429 | Target Detachable Coils | Stryker Neurovascular | 2016-06-22 | 30 | 0 |
| K153658 | Target Detachable Coils | Stryker Neurovascular | 2016-05-19 | 150 | 28 |
| K160096 | InZone Detachment System | Stryker Neurovascular | 2016-02-19 | 31 | 0 |
| K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcat | Stryker Neurovascular | 2014-11-14 | 63 | 0 |
| K132542 | TRANSGATE GUIDE CATHETER | Stryker Neurovascular | 2013-11-15 | 94 | 0 |
| K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER CO | Stryker Neurovascular | 2013-01-11 | 141 | 8 |
| K123377 | TARGET DETACHABLE COIL | Stryker Neurovascular | 2012-11-30 | 29 | 0 |
| K113778 | EXCELSIOR XT-27 MICROCATHETER | Stryker Neurovascular | 2012-04-20 | 120 | 3 |
| K120850 | TARGET DETACHABLE COIL | Stryker Neurovascular | 2012-04-17 | 27 | 1 |
| K113412 | TARGET DETACHABLE COIL | Stryker Neurovascular | 2011-12-13 | 25 | 28 |
| K112385 | TRAGET DETACHABLE COIL | Stryker Neurovascular | 2011-09-15 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda