Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568

• • Terminated Z-2793-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011 ·on shared 510(k) K031903

  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

K031903 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Steerable Stylet Accessory

  Class II

  FDA 510(k) K053019 Active Cleared 3 Mar 2006

• Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

  Class II

  FDA 510(k) K993588 Active Cleared 17 Nov 1999

• Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K031678 Active Cleared 26 Aug 2003

• ACS Hi-Torque Cross IT 100XT, 200XT, and 300XT Guide Wires with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K990639 Active Cleared 25 Mar 1999

• Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000 Open recall

  Class II

  FDA 510(k) K052274 Active Cleared 21 Sep 2005

• Omnilink .018 Biliary Stent System

  Class II

  FDA 510(k) K033834 Active Cleared 2 Jan 2004

See all devices from Guidant Corp. →