510(k) K242289
- Device
- Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
- Applicant
- Stryker Neurovascular
- 510(k) number
- K242289
- Product code
- QJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-21
- Date received
- 2024-08-02
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous, Neurovasculature
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Manmeet Chawla
- Address
- 47900 Bayside Pkwy. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3009965866
- 2027062
- 3013858269
- 3008824097
- 3031768596
- 3012931345
- 3016800412
- 2024311
- 3027319104
- 3013656790
- 3008853977
- 1721686
- 3031311812
- 3015615738
- 3009546466
- 3039020025
- 1048735
- 1721676
- 3005168196
- 3030088112
- 3003775027
- 3002807314
- 3014766734
- 3012543881
- 3014644549
- 1047843
- 3014211783
- 3017636737
- 3008264254
- 1220477
- 3011370111
- 3015453963
- 3007628272
- 2183744
- 3008114965
- 3019807891
- 3013556777
- 3008881809
- 3015701715
- 3013944123
- 3016591327
- 3024801436
- 3006451981
- 3017278832
- 3020954126
- 1035166
- 2030624
- 3009337401
- 3014779787
- 3006010712
- 3032047719
- 3017168767
- 3044156918
- 2011171
- 3013758550
- 3014590708
- 3000308637
- 3014162263
- 3025028711
- 1064858
- 3010079067
- 2029214
- 3003780911
- 3012497308
- 3017210488
- 3004063494
- 3008837339
- 3016522967
- 3007007790
- 3014758755
- 9612501
- 3009380063
- 9617601
- 3014498720
- 3015550451
- 3009057691
Source Documents#
Other 510(k) Records For Product Code QJP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260199 | SLIM Microcatheter | Balt USA, LLC | 2026-07-13 |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026-07-09 |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026-07-01 |
| K261808 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 |
| K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026-05-11 |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | 2026-04-21 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026-04-16 |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | 2026-04-15 |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | 2026-04-09 |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 2026-01-16 |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 2026-01-06 |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026-01-05 |