510(k) K200198 ยท NTE Temporary Carotid Catheter For Embolic Capture
WIRION
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Mar 18, 2020 |
| Received | Jan 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200198
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.