510(k) K241708 ยท DYB Introducer, Catheter
Abiomed 14Fr Low Profile Introducer Kit
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Aug 6, 2024 |
| Received | Jun 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2026 | Abiomed, Inc. Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. Open, Classified |
DYB | None listed |
| Jun 25, 2026 | Abiomed, Inc. Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435. Open, Classified |
DYB | None listed |
| Jun 25, 2026 | Abiomed, Inc. Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. Open, Classified |
DYB | None listed |
| Jun 25, 2026 | Abiomed, Inc. Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.