510(k) K122084 ยท DYB Introducer, Catheter
INTRODUCER SET, MODEL ADELANTE-S SERIES
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Aug 29, 2012 |
| Received | Jul 16, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3025, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories. Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3021, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories. Open, Classified |
DYB | None listed |
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3006, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. Open, Classified |
DYB | None listed |
| Feb 22, 2021 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer
Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.