510(k) K102025
K102025 is an FDA 510(k) premarket notification submitted by Combat Medical Systems, LLC for the device "COMBAT READY CLAMP". The FDA issued a decision of Substantially Equivalent on August 11, 2010. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Combat Medical Systems, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2010
- Date Received
- July 19, 2010
- 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