510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192460Substantially Equivalent

Sentinel Cerebral Protection System

Boston Scientific Corporation, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192460 is the FDA 510(k) clearance record for Sentinel Cerebral Protection System, a class II device, cleared for Boston Scientific Corporation 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 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K192460.

Clearance record

Decision date
Received
(163 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
Boston Scientific Corporation Three Scimed Pl., Maple Grove MN
510(k) summary
Summary PDF
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