510(k) K910021

CARDIOPULMONARY BYPASS PUMP TUBING by Jtl Medical Corp. — Product Code DWF

K910021 is an FDA 510(k) premarket notification submitted by Jtl Medical Corp. for the device "CARDIOPULMONARY BYPASS PUMP TUBING". The FDA issued a decision of Substantially Equivalent on May 22, 1991. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Jtl Medical Corp. has at least 2 other 510(k) clearances on record.