510(k) K092895 ยท DTZ Oxygenator, Cardiopulmonary Bypass
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Oct 19, 2009 |
| Received | Sep 21, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092895
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2012 | Sorin Group USA, Inc. Apex HP 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, 86, Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.