510(k) K062569
K062569 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING". The FDA issued a decision of Substantially Equivalent on February 14, 2007. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Datascope Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2007
- Date Received
- August 31, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type