510(k) K172494

PROTEUS PTA Balloon Catheter with Embolic Capture Feature by Angioslide, Ltd. — Product Code LIT

K172494 is an FDA 510(k) premarket notification submitted by Angioslide, Ltd. for the device "PROTEUS PTA Balloon Catheter with Embolic Capture Feature". The FDA issued a decision of Substantially Equivalent on Dec 15, 2017. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Angioslide, Ltd. has 5 other 510(k) clearances on record.