510(k) K023381 ยท DTZ Oxygenator, Cardiopulmonary Bypass
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 31, 2003 |
| Received | Oct 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Jul 20, 2004 | Gish Biomedical Inc Vision Hollow Fiber Oxygenator with GBS Coating Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.