Cook Vascular Vital-Ject Power Injectable Safety Infusion Set
FDA 510(k) K083482 · Cook Vascular, Inc.
510(k) numberK083482
Submission
- Device name
- Cook Vascular Vital-Ject Power Injectable Safety Infusion Set
- Applicant
- Cook Vascular, Inc.
Vandergrift, PA, US - Received
- November 24, 2008
- Decision date
- April 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Cook Vascular Vital-Ject Power Injectable Safety Infusion Set cleared by the FDA?
Cook Vascular Vital-Ject Power Injectable Safety Infusion Set (K083482) received a 510(k) decision of Substantially Equivalent on April 2, 2009, 129 days after the submission was received.
What is the product code of K083482?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.