510(k) K072167
K072167 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE". The FDA issued a decision of Substantially Equivalent on September 6, 2007. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Advanced Vascular Dynamics has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2007
- Date Received
- August 6, 2007
- Clearance Type
- Special
- 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