Panels › Cardiovascular › Product code PUM · Class 2
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Regulation 870.1251
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PUM
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 1 | 0 |
| Claret Medical, Inc. | 1 | 0 |
| Emboline, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K261715 | Emboliner Embolic Protection System (EPC-03) Emboline, Inc. | PUM |
| Feb 19, 2020 | K192460 | Sentinel Cerebral Protection System Boston Scientific Corporation | PUM |
| Jun 1, 2017 | DEN160043 | Sentinel Cerebral Protection System Claret Medical, Inc. | PUM |
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