510(k) K000255 ยท DTZ Oxygenator, Cardiopulmonary Bypass
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Apr 25, 2000 |
| Received | Jan 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc.. Terminated |
DTZ | None listed |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 07 Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.