I-Flow Elastomeric Pump with Bolus

• • Terminated Z-2253-2012 FDA Class I ·initiated 8 May 2012

  It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.

510(k) Number

K023318 ↗

FDA Product Code

MEB

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Soaker Catheter

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• Titan Driver 60cc, 30 Minute Administration Set

  Class II

  FDA 510(k) K953028 Active Cleared 28 Sep 1995

• Paragon Infusion System

  Class II

  FDA 510(k) K020251 Active Cleared 15 Feb 2002

• Sidekick Infusion Kit

  Class II

  FDA 510(k) K990425 Active Cleared 23 Apr 1999

• Homepump C-Series and Homepump C-Series One-Step Kvo

  Class II

  FDA 510(k) K991513 Active Cleared 21 Jun 1999

See all devices from I-Flow Corp. →