510(k) K011318

VENODYNE DVT ADVANTAGE PLUS by Microtek Medical, Inc. — Product Code JOW

K011318 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "VENODYNE DVT ADVANTAGE PLUS". The FDA issued a decision of Substantially Equivalent on October 25, 2001. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.