FDA 510(k), K134031, THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER

510(K) Number: K134031
Device Name: THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
Manufacturer: Boston Scientific Corporation
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 12/31/2013
Decision Date: 07/21/2014
Regulation Medical Specialty: Cardiovascular