PUM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1251
- Medical specialty
- Cardiovascular
- FDA definition
- Embolic protection for transcatheter intracardiac procedures
- Adverse events (MAUDE)
- 2021: 43 · 2022: 40 · 2023: 24 · 2024: 45 · 2025: 50 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Sentinel Cerebral Protection System (K192460) | Boston Scientific Corporation | 2020-02-19 | + Add |
| Sentinel Cerebral Protection System (DEN160043) | Claret Medical, Inc. | 2017-06-01 |
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Every clearance here is in the API, with alerts when new ones post.