510(k) K981035

PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES by Sims Portex, Inc. — Product Code JKA

K981035 is an FDA 510(k) premarket notification submitted by Sims Portex, Inc. for the device "PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES". The FDA issued a decision of Substantially Equivalent on April 21, 1998. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sims Portex, Inc. has at least 10 other 510(k) clearances on record.