510(k) K974812 ยท DTZ Oxygenator, Cardiopulmonary Bypass
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Jun 1, 1998 |
| Received | Dec 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc.. Terminated |
DTZ | None listed |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.