510(k) K222113 ยท DYB Introducer, Catheter
Abiomed 14Fr Low Profile Introducer Set
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Oct 13, 2022 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2023 | Abiomed, Inc. Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.