Amplatz Goose Neck Snare Kit/ Catheter

• • Terminated Z-0992-2007 FDA Unclassified (pre-2012) ·initiated 18 May 2007

  Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.

510(k) Number

K972511 ↗

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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