510(k) K231401

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva by Poly Medicure Limited — Product Code FOZ

K231401 is an FDA 510(k) premarket notification submitted by Poly Medicure Limited for the device "Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva". The FDA issued a decision of Substantially Equivalent on September 21, 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.