510(k) K112384
K112384 is an FDA 510(k) premarket notification submitted by Compression Works, LLC for the device "ABDOMINAL TOURNIQUET SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2011. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Compression Works, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2011
- Date Received
- August 18, 2011
- 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