510(k) K893546

OPTICALLY CLEAR RADIOPAQUE CATHETER by Critikon Company, LLC — Product Code FOZ

K893546 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "OPTICALLY CLEAR RADIOPAQUE CATHETER". The FDA issued a decision of Substantially Equivalent on November 1, 1989. 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. Critikon Company, LLC has at least 10 other 510(k) clearances on record.