510(k) K123077
K123077 is an FDA 510(k) premarket notification submitted by Hebumedical GmbH for the device "VASCULAR CLAMPS". The FDA issued a decision of Substantially Equivalent on May 14, 2013. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2013
- Date Received
- Oct 1, 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
- 510(k)