510(k) K130482

COMBAT READY CLAMP by Combat Medical Systems, LLC — Product Code DXC

K130482 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 April 29, 2013. 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
April 29, 2013
Date Received
February 25, 2013
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