510(k) K040355 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 15, 2004 |
| Received | Feb 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.