510(k) K953298

MS CLASSIQUE BALLOON DIATATION CATHETER by Meadox Medicals, Div. Boston Scientific Corp. — Product Code LIT

K953298 is an FDA 510(k) premarket notification submitted by Meadox Medicals, Div. Boston Scientific Corp. for the device "MS CLASSIQUE BALLOON DIATATION CATHETER". The FDA issued a decision of Substantially Equivalent on February 8, 1996. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Meadox Medicals, Div. Boston Scientific Corp. has at least 10 other 510(k) clearances on record.