510(k) K122405
K122405 is an FDA 510(k) premarket notification submitted by Datascope Corp., Cardiac Assist Division for the device "AIR-BAND RADIAL COMPRESSION DEVICE". The FDA issued a decision of Substantially Equivalent on November 9, 2012. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Datascope Corp., Cardiac Assist Division has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2012
- Date Received
- August 7, 2012
- Clearance Type
- Traditional
- 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