Model Pc-2 Volumetric Infusion Pump/Controller

• • Terminated Z-1020-2007 FDA Unclassified (pre-2012) ·initiated 18 Jun 2007

  It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.k.a. Flo-Stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. The over-infusion occurrence is dependent on the user not closing the roller clamp first, as required by clinical practi

510(k) Number

K862295 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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