510(k) K070323
K070323 is an FDA 510(k) premarket notification submitted by Vascutek, Ltd. for the device "TEMPORARY LIMB SALVAGE SHUNT". The FDA issued a decision of Substantially Equivalent on February 15, 2007. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Vascutek, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2007
- Date Received
- February 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- Yes
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type