Copilot Bleedback Control Valve, Model 1003331

• • Terminated Z-2792-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011

  Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.

510(k) Number

K991102 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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