FDA Product Code
FDA Product Code PUM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1251
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261715 | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | 2026-09-08 | Traditional | PDF ↗ |
| K192460 | Sentinel Cerebral Protection System | Boston Scientific Corporation | 2020-02-19 | Special | PDF ↗ |
| DEN160043 | Sentinel Cerebral Protection System | Claret Medical, Inc. | 2017-06-01 | Direct | — |
Product code PUM · Class II · Cardiovascular. Data: openFDA.