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0.9% Sodium Chloride Diluent In Plastic Syringe

by Abbott Laboratories

510(k) K953805

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953805 Date28 Jun 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 0.9% Sodium Chloride Diluent in Plastic Syringe is an intravascular, therapeutic catheter device intended for short-term use of less than 30 days. It functions as a delivery system for the saline diluent contained within the plastic syringe.

This device is supplied by Abbott Laboratories and has received FDA 510(k) clearance. It is classified as a Class II medical device under product code FOZ.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of this device?

    This device is an intravascular, therapeutic catheter system designed to deliver 0.9% sodium chloride diluent. It is intended for short-term clinical applications lasting less than 30 days.

  • How is this device classified for regulatory purposes?

    The device is classified as a Class II medical device under product code FOZ. It has received FDA 510(k) clearance, indicating it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of this diluent syringe?

    This product is manufactured by Abbott Laboratories, located in Abbott Park, Illinois. The device was cleared for use under the FDA 510(k) submission number K953805.