510(k) K071140

MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 by Top Spins, Inc. — Product Code KCY

K071140 is an FDA 510(k) premarket notification submitted by Top Spins, Inc. for the device "MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002". The FDA issued a decision of Substantially Equivalent on June 7, 2007. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Top Spins, Inc. has at least 2 other 510(k) clearances on record.