510(k) K083482

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET by Cook Vascular, Inc. — Product Code FPA

K083482 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET". The FDA issued a decision of Substantially Equivalent on April 2, 2009. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cook Vascular, Inc. has at least 10 other 510(k) clearances on record.