510(k) K202330 ยท DYB Introducer, Catheter
Impella XR Sheath Set
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Dec 7, 2020 |
| Received | Aug 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202330
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.