510(k) K192769 ยท DYB Introducer, Catheter
Impella CP Introducer
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Nov 18, 2019 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192769
| 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 |
| Jan 5, 2024 | Abiomed, Inc. Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body.
Part Number: 0052-3006
Individual, and Part of Pump Set (005062, 0550-0008, 1 Open, Classified |
DYB | None listed |
| Jan 5, 2024 | Abiomed, Inc. Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body.
Part Number: 0052-3014 Open, Classified |
DYB | None listed |
| Jan 5, 2024 | Abiomed, Inc. Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body.
Part Number: 0052-3015 Open, Classified |
DYB | None listed |
| Jan 5, 2024 | Abiomed, Inc. Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002)
Part Number: 0052-3021.
Intended for introduction of the Impella Catheter into the bod Open, Classified |
DYB | None listed |
| Jan 5, 2024 | Abiomed, Inc. Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body.
Part Number: 0052-3052 Open, Classified |
DYB | None listed |
| Jan 5, 2024 | Abiomed, Inc. Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body.
Part Number: 0052-0053 Open, Classified |
DYB | None listed |
| Jan 5, 2024 | Abiomed, Inc. Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body.
Part Number: 0052-3 Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.