510(k) K192460 ยท PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Sentinel Cerebral Protection System
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 19, 2020 |
| Received | Sep 9, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192460
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.