510(k) K981258

MANAN MALECOT BASKET DRAINAGE CATHETER by Medical Device Technologies, Inc. — Product Code FEW

K981258 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "MANAN MALECOT BASKET DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on April 22, 1998. The device falls under product code FEW (Catheter, Malecot), a Class II device regulated under 21 CFR 876.5090. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.