510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160043Unknown

Sentinel Cerebral Protection System

Claret Medical, Inc., Santa Rosa CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160043 is the FDA 510(k) clearance record for Sentinel Cerebral Protection System, a class II device, cleared for Claret Medical, Inc. on under FDA product code PUM (Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures). FDA's definition for product code PUM reads: "Embolic protection for transcatheter intracardiac procedures". FDA records list one 510(k) clearance for Claret Medical, Inc. As of , FDA records show no recalls naming DEN160043.

Clearance record

Decision date
Received
(254 days to decision)
Product code
PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Regulation
21 CFR 870.1251
Device class
Class II
Review panel
Cardiovascular
Applicant
Claret Medical, Inc. 1745 Copperhill Pkwy., Suite 1, Santa Rosa CA
Third party review
No

Clearances, product code PUM

Trailing 12 months
1 clearance under product code PUM in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PUM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260