510(k) K033323 ยท DTZ Oxygenator, Cardiopulmonary Bypass
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Jan 13, 2004 |
| Received | Oct 15, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K033323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2012 | Sorin Group USA, Inc. D 903 Avant Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.