Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe

• • 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

K112086 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. Bcr-15

  Class II

  FDA 510(k) K952235 Active Cleared 26 Jun 1995

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

  Class II

  FDA 510(k) K960901 Active Cleared 29 May 1996

• Benzalkonium-Heparin Coated Guidewires

  Class II

  FDA 510(k) K802473 Active Cleared 12 Nov 1980

• Medrad Counterpoise System

  Class II

  FDA 510(k) K944983 Active Cleared 29 Nov 1994

• Medrad Fluoroscopic Video Enhancement System

  Class II

  FDA 510(k) K884317 Active Cleared 20 Dec 1988

• Mrinnervu Endorectal Prostate Coil

  Class II

  FDA 510(k) K925029 Active Cleared 19 May 1993

See all devices from Medrad, Inc. →