TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
FDA 510(k) clearance K203764 · decided 2021-03-03
Clearance details
- K-number
- K203764
- Device name
- TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
- Applicant
- Imperative Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-23
- Decision date
- 2021-03-03
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- QJP
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Campbell, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SLIM Microcatheter (K260199) | Balt USA, LLC | 2026-07-13 |
| Millipede88 Access Catheter (K253901) | Perfuze, Ltd. | 2026-07-09 |
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
| ISAAC Neurovascular Navigation Catheter (K261808) | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 |
| BOBBY Balloon Guide Catheter (K261549) | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 |
| Zenith Distal Access Long Sheath (K253359) | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| SAYA 86 Radial Access Guide Catheter (K254178) | Asahi Intecc Co., Ltd. | 2026-05-11 |
| BosCATH Support Catheter (K254046) | Sonorous NV, Inc. | 2026-04-21 |
| Next Generation 088 Catheter (K254223) | Balt USA, LLC | 2026-04-16 |
| PATH BGC (K260938) | Crossroads Neurovascular, Inc. | 2026-04-15 |
| Radical 6F Access Catheter (K253975) | Maduro Medical, Inc. | 2026-04-09 |
| AXS Lift Intracranial Base Catheter (K253032) | Stryker Neurovascular | 2026-02-11 |
Recalls involving this device
No recalls on record reference this clearance.