510(k) K891013

MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING by Medtronic Vascular — Product Code CCC

K891013 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING". The FDA issued a decision of Substantially Equivalent on August 2, 1989. The device falls under product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1150. Medtronic Vascular has at least 10 other 510(k) clearances on record.