Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days (LJS) (1) Transducer, Blood-Pressure, Extravascular (DRS) (1)