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Avi Model 4206 Manifold Checkvalve IV Admin. Set

by 3M Avi, Inc.

510(k) K902858

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 NumberK902858 Date14 Dec 1990ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Avi Model 4206 Manifold Checkvalve IV Administration Set is an intravascular administration set. It is designed to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

This device is classified as a Class II medical device under product code FPA. It received FDA 510(k) clearance on December 14, 1990, under K902858.

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Questions

AI-generated answers, 25 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 primary function of the Avi Model 4206?

    The Avi Model 4206 is an intravascular administration set designed to facilitate the delivery of fluids from a container directly into a patient's vascular system through a needle or catheter inserted into a vein.

  • What is the regulatory status of this administration set?

    The Avi Model 4206 is classified as a Class II medical device under product code FPA. It received FDA 510(k) clearance on December 14, 1990, under submission number K902858.

  • Who is the manufacturer of the Model 4206 IV set?

    This device is manufactured by 3M Avi, Inc., located in St. Paul, Minnesota.