K-Shield Port Access Infusion Set with High Pressure Tubing

• • Terminated Z-0826-2014 FDA Class II ·initiated 25 Nov 2013

  Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

510(k) Number

K100720 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Kawasumi Laboratories Co., Ltd. →