510(k) K012942 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
| Applicant | Circulatory Technology, Inc., Oyster Bay NY, US |
| Decision | Substantially Equivalent, Nov 5, 2001 |
| Received | Aug 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012942
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.