Cook Vascular Peel-Away Hemostasis Valve
FDA 510(k) K010128 · Cook Vascular, Inc.
510(k) numberK010128
Submission
- Device name
- Cook Vascular Peel-Away Hemostasis Valve
- Applicant
- Cook Vascular, Inc.
Leechburg, PA, US - Received
- January 16, 2001
- Decision date
- April 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Cook Vascular Peel-Away Hemostasis Valve cleared by the FDA?
Cook Vascular Peel-Away Hemostasis Valve (K010128) received a 510(k) decision of Substantially Equivalent on April 25, 2002, 464 days after the submission was received.
What is the product code of K010128?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.