Amplatz Goose-Neck Snare

• • Terminated Z-0894-06 FDA Unclassified (pre-2012) ·initiated 16 Aug 2005

  ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.

510(k) Number

K901502 ↗

FDA Product Code

DXE

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Amplatz Goose Neck Snare Kit/ Catheter

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