510(k) K041771

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

K041771 is an FDA 510(k) premarket notification submitted by Twin Star Medical, Inc. for the device "TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 2004. 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.