PUM · Class II · 21 CFR 870.1251

FDA Product Code PUM: Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Embolic Protection For Transcatheter Intracardiac Procedures

Leading manufacturers include Claret Medical, Inc. and Boston Scientific Corporation.

2
Total
1
Cleared
209d
Avg days
2017
Since

FDA 510(k) Cleared Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures Devices (Product Code PUM)

2 devices
1–2 of 2
Cleared Feb 19, 2020
Sentinel Cerebral Protection System
K192460
Boston Scientific Corporation
Cardiovascular · 163d
Not Cleared Jun 01, 2017
Sentinel Cerebral Protection System
DEN160043
Claret Medical, Inc.
Cardiovascular · 254d

About Product Code PUM - Regulatory Context