Rapido Cut-a-Way Rotating Hemostasis Valve

• • Terminated Z-2793-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011 ·on shared 510(k) K031688

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K031688 ↗

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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