510(k) K130639 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
| Applicant | Maquet Cardiopulmonary, AG, Rastatt De-Bw, DE |
| Decision | Substantially Equivalent, May 16, 2013 |
| Received | Mar 11, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130639
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.