510(k) K230616

Polyguard and Polyshield Safety IV Catheters by Poly Medicure Limited — Product Code FOZ

K230616 is an FDA 510(k) premarket notification submitted by Poly Medicure Limited for the device "Polyguard and Polyshield Safety IV Catheters". The FDA issued a decision of Substantially Equivalent on May 5, 2023. 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. Poly Medicure Limited has at least 5 other 510(k) clearances on record.