Safeguard 24 CM Pressure Assisted Dressing
FDA 510(k) K062569 · Datascope Corp.
510(k) numberK062569
Submission
- Device name
- Safeguard 24 CM Pressure Assisted Dressing
- Applicant
- Datascope Corp.
Manwah, NJ, US - Received
- August 31, 2006
- Decision date
- February 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Safeguard 24 CM Pressure Assisted Dressing cleared by the FDA?
Safeguard 24 CM Pressure Assisted Dressing (K062569) received a 510(k) decision of Substantially Equivalent on February 14, 2007, 167 days after the submission was received.
What is the product code of K062569?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.