Modification to Renegade Fiber Braided Microcatheter

• • Terminated Z-2246-2009 FDA Unclassified (pre-2012) ·initiated 26 Aug 2009 ·on shared 510(k) K020012

  Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.

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

510(k) Number

K020012 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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