FDA 510(k), K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit

510(K) Number: K143538
Device Name: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Manufacturer: BAYER MEDICAL CARE INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 12/15/2014
Decision Date: 08/14/2015
Regulation Medical Specialty: Cardiovascular

787 pages (23,381 of 24,168 original pages are fully redacted)