510(k) K020997 ยท DTZ Oxygenator, Cardiopulmonary Bypass
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 4, 2002 |
| Received | Mar 28, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2012 | Sorin Group USA, Inc. Apex SMART PHisio 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 Terminated |
DTZ | None listed |
| Jan 14, 2012 | Sorin Group USA, Inc. Apex Phisio 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.