ViaValve Safety I.V. Catheter

• • Terminated Z-1218-2019 FDA Class II ·initiated 22 Aug 2018

  Several lots of Jelco ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.

510(k) Number

K160235 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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