510(k) DEN160043
- Device
- Sentinel Cerebral Protection System
- Applicant
- Claret Medical, Inc.
- 510(k) number
- DEN160043
- Product code
- PUM
- Decision
- Unknown (DENG)
- Decision date
- 2017-06-01
- Date received
- 2016-09-20
- Regulation
- 870.1251
- Classification name
- Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Zachary Woodson
- Address
- 1745 Copperhill Pkwy., Suite 1 Santa Rosa CA US 95403 95403
FDA Registration Numbers#
- 3012448339
- 3003678543
- 2134265
- 2124215
- 3007695959
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PUM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192460 | Sentinel Cerebral Protection System | Boston Scientific Corporation | 2020-02-19 |