510(k) K945258

CATCO URINARY COLLECTION KIT by Catco Medical, Inc. — Product Code FCN

K945258 is an FDA 510(k) premarket notification submitted by Catco Medical, Inc. for the device "CATCO URINARY COLLECTION KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on February 16, 1995. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Catco Medical, Inc. has at least 10 other 510(k) clearances on record.