Sentinel Cerebral Protection System
FDA 510(k) clearance DEN160043 · decided 2017-06-01
Clearance details
- K-number
- DEN160043
- Device name
- Sentinel Cerebral Protection System
- Applicant
- Claret Medical, Inc.
- Decision
- Unknown
- Date received
- 2016-09-20
- Decision date
- 2017-06-01
- Days to decision
- 254 days
- Clearance type
- Direct
- Product code
- PUM
- Device class
- 2
- Regulation number
- 870.1251
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Rosa, 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 |
|---|---|---|
| Sentinel Cerebral Protection System (K192460) | Boston Scientific Corporation | 2020-02-19 |
Recalls involving this device
No recalls on record reference this clearance.