D-Stat Handle, Model 8500-053
FDA 510(k) K063871 · Vascular Solutions, Inc.
510(k) numberK063871
Submission
- Device name
- D-Stat Handle, Model 8500-053
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- December 29, 2006
- Decision date
- February 28, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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Questions and answers
When was D-Stat Handle, Model 8500-053 cleared by the FDA?
D-Stat Handle, Model 8500-053 (K063871) received a 510(k) decision of Substantially Equivalent on February 28, 2007, 61 days after the submission was received.
What is the product code of K063871?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.