510(k) K140805
K140805 is an FDA 510(k) premarket notification submitted by Innovative Trauma Care, Inc. for the device "ITCLAMP 50". The FDA issued a decision of Substantially Equivalent on Oct 9, 2014. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Innovative Trauma Care, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2014
- Date Received
- Apr 1, 2014
- 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)