510(k) K131966

TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM by Twin Star Medical, Inc. — Product Code LXC

K131966 is an FDA 510(k) premarket notification submitted by Twin Star Medical, Inc. for the device "TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2014. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device. Twin Star Medical, Inc. has at least 3 other 510(k) clearances on record.