Medrad Mark V-Plus Injector

• • Terminated Z-0745-2019 FDA Class II ·initiated 14 Dec 2018

  If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

510(k) Number

K903390 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Benzalkonium-Heparin Coated Guidewires

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