Lifeport Attachable System W/Inducer Kit Lps 5555

• • Terminated Z-0405-2011 FDA Unclassified (pre-2012) ·initiated 27 Sep 2010 ·on shared 510(k) K915273

  Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K915273 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

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