510(k) K954147

MANAN MALECOT BASKET DRAINAGE CATHETER by Manan Medical Products, Inc. — Product Code FEW

K954147 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MANAN MALECOT BASKET DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on March 26, 1996. The device falls under product code FEW (Catheter, Malecot), a Class II device regulated under 21 CFR 876.5090. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.