510(k) K201116 ยท DYB Introducer, Catheter
Abiomed 23 Fr Sheath
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Jun 15, 2020 |
| Received | Apr 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.