Panels › Cardiovascular › Product code DTZ · Class 2
Oxygenator, Cardiopulmonary Bypass
Regulation 870.4350
5510(k)s in 12 months (255 all time)
0recalls in 12 months (107 all time)
98recalls that name a 510(k)
Top companies in DTZ
| 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 | K000255 K963518 |
| 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 | K926467 K974812 |
| Mar 1, 2006 | Gish Biomedical Inc The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The Terminated |
DTZ | K040355 |
| Feb 14, 2006 | Gish Biomedical Inc The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorp Terminated |
DTZ | K023381 |
| Aug 24, 2005 | Boston Scientific Corp ''NAMIC Custom Angiographic Kit'' sold under the following labels:
(1) Medical University of South Carolina. Pouch Catalog # 60131481;
(2) Covenant Medical Center, Pouch Catalog #60131603;
(3) St Terminated |
DTZ | K782095 |
| Jul 20, 2004 | Medtronic Perfusion Systems Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R Terminated |
DTZ | K936003 K973760 |
| Jul 20, 2004 | Gish Biomedical Inc Vision Hollow Fiber Oxygenator with GBS Coating Terminated |
DTZ | K023381 |
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