Arrow Echogenic Introducer Needle Component

• 2 recalls, same reason

  • Terminated Z-2022-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1959-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

510(k) Number

K071998 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Needleless Injection Cannula

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• 8 Fr.-40cc Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.SHEATH)

  Class II

  FDA 510(k) K960713 Active Cleared 15 May 1996

See all devices from Arrow Intl., Inc. →