510(k) K991452 ยท DTZ Oxygenator, Cardiopulmonary Bypass
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Oct 7, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc.. Terminated |
DTZ | None listed |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc.. Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.