Two Fluid W/Check Valve

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K871843 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Three Fluid I.V. Sets

  Class II

  FDA 510(k) K871841 Active Cleared 24 Jun 1987

• Low Volume Extension Set

  Class II

  FDA 510(k) K864395 Active Cleared 16 Dec 1986

• Two Fluid I.V. Sets

  Class II

  FDA 510(k) K871842 Active Cleared 24 Jun 1987

• Graseby Pcas Model No. 0124-0701, Pvs Dytinhr Pump

  Class II

  FDA 510(k) K865051 Active Cleared 10 Feb 1987

• Nutrition Delivery Sets for Vm 05 Ambula. Pump

  Class II

  FDA 510(k) K871848 Active Cleared 3 Feb 1988

• What is the Two Fluid W/Check Valve used for?

  The Two Fluid W/Check Valve is a medical device designed for fluid management systems in hospital settings. It incorporates a check valve mechanism to regulate fluid flow specifically in two-fluid applications, ensuring proper fluid control and direction.

• How is the Two Fluid W/Check Valve supplied?

  The device is supplied by Panamedix, Inc. and is classified under product code FPA. It is manufactured at their facility located at 1308-E Logan Ave., Costa Mesa, CA 92626, and is intended for use in hospital environments.

• What is the regulatory status of the Two Fluid W/Check Valve?

  The device received FDA 510(k) clearance with K number K871843 on July 21, 1987. It has been determined to be substantially equivalent to predicate devices and is classified under product code FPA for general hospital use.

• Is the Two Fluid W/Check Valve single-use or reusable?

  The device data does not specify whether the Two Fluid W/Check Valve is designed for single-use or multiple uses. For proper usage instructions and sterilization procedures, please refer to the manufacturer's documentation or contact Panamedix, Inc. directly.