Adroit Guiding Catheter

• • Terminated Z-0003-2014 FDA Class II ·initiated 12 Aug 2013

  Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.

510(k) Number

K131225 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cordis Corp., A Johnson & Johnson Co. →