Acs Viking Guiding Catheter

• 2 recalls, same reason

  • Terminated Z-1634-2008 FDA Unclassified (pre-2012) ·initiated 17 Mar 2008
  • Terminated Z-1633-2008 FDA Unclassified (pre-2012) ·initiated 17 Mar 2008

  Mislabeling: The part number on the product label packaging may not match the product.

510(k) Number

K972484 ↗

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 Guidant Corp. →