510(k) K904944

TRANSLUMINAL ENDARTERECTOMY DEVICE by Baxter Healthcare Corp — Product Code DWX

K904944 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "TRANSLUMINAL ENDARTERECTOMY DEVICE". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.