510(k) K994243

DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP by Heartport, Inc. — Product Code DWF

K994243 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP". The FDA issued a decision of Substantially Equivalent on May 5, 2000. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Heartport, Inc. has at least 10 other 510(k) clearances on record.