510(k) K023622

STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 by Stockert Instrumente GmbH — Product Code DWF

K023622 is an FDA 510(k) premarket notification submitted by Stockert Instrumente GmbH for the device "STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35". The FDA issued a decision of Substantially Equivalent on November 21, 2002. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Stockert Instrumente GmbH has at least 8 other 510(k) clearances on record.