QJP — Catheter, Percutaneous, Neurovasculature Class II
FDA product code QJP covers "Catheter, Percutaneous, Neurovasculature", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJP
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260199 | balt usa | SLIM Microcatheter | July 13, 2026 |
| K253901 | perfuze | Millipede88 Access Catheter | July 9, 2026 |
| K261889 | stryker neurovascular | Trevo Trak 21 Microcatheter | July 1, 2026 |
| K261808 | microvention inc. d/b/a terumo neuro | ISAAC Neurovascular Navigation Catheter | June 30, 2026 |
| K261549 | microvention, inc., d/b/a terumo neuro | BOBBY Balloon Guide Catheter | June 9, 2026 |
| K253359 | suzhou zenith vascular scitech limited | Zenith Distal Access Long Sheath | May 22, 2026 |
| K254178 | asahi intecc co | SAYA 86 Radial Access Guide Catheter | May 11, 2026 |
| K254046 | sonorous nv | BosCATH Support Catheter | April 21, 2026 |
| K254223 | balt usa | Next Generation 088 Catheter | April 16, 2026 |
| K260938 | crossroads neurovascular | PATH BGC | April 15, 2026 |
| K253975 | maduro medical | Radical 6F Access Catheter | April 9, 2026 |
| K253032 | stryker neurovascular | AXS Lift Intracranial Base Catheter | February 11, 2026 |
| K252297 | toro neurovascular | Toro 88 Superbore Catheter | January 16, 2026 |
| K251097 | vesalio | V-DAC Catheter | January 6, 2026 |
| K251668 | kaneka americas holding | SurfRider 13 Microcatheter | January 5, 2026 |
| K252213 | bend it technologies | Bendit17 Microcatheter | December 3, 2025 |
| K251372 | unity medical | VersaD Delivery Catheter | October 24, 2025 |
| K252569 | balt usa | Carrier XL Delivery Catheter | October 22, 2025 |
| K250960 | rev neuro | DUO Microcatheter | September 8, 2025 |
| K251560 | asahi intecc co | FUBUKI XF-R Neurovascular Long Sheath | June 20, 2025 |