510(k) K993816

BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD by Baxter Edwards — Product Code MCW

K993816 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD". The FDA issued a decision of Substantially Equivalent on May 4, 2000. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Baxter Edwards has at least 10 other 510(k) clearances on record.