510(k) K910372

INTIMAX THROMBECTOMY CATHETER by Applied Vascular Devices, Inc. — Product Code DXE

K910372 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "INTIMAX THROMBECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on April 26, 1991. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.