Syringes

• • Ongoing Z-1591-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

510(k) Number

K760392 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Extension Sets

  Class I

  FDA 510(k) K760385 Active Cleared 2 Nov 1976

• Catheter, Vein (Venofix)

  Class II

  FDA 510(k) K760388 Active Cleared 2 Nov 1976

• Stoppers

  Class I

  FDA 510(k) K760384 Active Cleared 2 Nov 1976

• Cannula, Iv

  Class I

  FDA 510(k) K760389 Active Cleared 2 Nov 1976

• Connectors

  Class I

  FDA 510(k) K760382 Active Cleared 2 Nov 1976

• Central Veinous Pressure Sets

  Class II

  FDA 510(k) K760386 Active Cleared 2 Nov 1976

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