ClearanceBrief
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

ApplicantMaquet Cardiopulmonary, AG, Rastatt De-Bw, DE
DecisionSubstantially Equivalent, May 16, 2013
ReceivedMar 11, 2013
TypeSpecial
FDA recordOpen 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.