510(k) K944367

CATCO POLYURETHANE UMBILICAL VESSEL CATHETER by Catco Medical, Inc. — Product Code FOZ

K944367 is an FDA 510(k) premarket notification submitted by Catco Medical, Inc. for the device "CATCO POLYURETHANE UMBILICAL VESSEL CATHETER". The FDA issued a decision of Substantially Equivalent on April 5, 1995. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Catco Medical, Inc. has at least 10 other 510(k) clearances on record.