510(k) DEN160043
DEN160043 is an FDA 510(k) premarket notification submitted by Claret Medical, Inc. for the device "Sentinel Cerebral Protection System". The FDA issued a decision of De Novo Granted on June 1, 2017. The device falls under product code PUM (Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures), a Class II device regulated under 21 CFR 870.1251.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 1, 2017
- Date Received
- September 20, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Device Class
- Class II
- Regulation Number
- 870.1251
- Review Panel
- CV
- Submission Type
Embolic protection for transcatheter intracardiac procedures