510(k) K043323 ยท DTZ Oxygenator, Cardiopulmonary Bypass
D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
| Applicant | Dideco S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 1, 2005 |
| Received | Dec 2, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2012 | Sorin Group USA, Inc. D 905 EOS 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, 8 Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.