Product code PUM— Cardiovascular
Sentinel Cerebral Protection System
- Classification name
- Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Device class
- Class 2
- Regulation
- 21 CFR 870.1251
- Advisory panel
- Cardiovascular
- Total cleared
- 3
- First cleared
- Most recent
FDA classification definition
“Embolic protection for transcatheter intracardiac procedures”
Market context for product code PUM
FDA has cleared devices under product code PUM between 2017 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2020
- 2017
Top applicants under product code PUM
Adverse events under product code PUM
product code PUM- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.