510(k) K032632

REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH by Estech, Inc. — Product Code DWF

K032632 is an FDA 510(k) premarket notification submitted by Estech, Inc. for the device "REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH". The FDA issued a decision of Substantially Equivalent on October 22, 2003. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Estech, Inc. has at least 6 other 510(k) clearances on record.