510(k) K875177

J&J SCALP VEIN INFUSION SETS by Critikon Company, LLC — Product Code FOZ

K875177 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "J&J SCALP VEIN INFUSION SETS". The FDA issued a decision of Substantially Equivalent on January 14, 1988. 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.