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Arteria Blood Filter

by Arteria Medical Science, Inc.

510(k) K021293

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 NumberK021293 Date22 Aug 2002ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 21 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 Arteria Blood Filter is a blood transfusion filter and drip chamber assembly. It consists of a filter and drip chamber integrated with flexible medical-grade tubing, featuring a three-way stopcock valve with male and female Luer connections on the input side and a male Luer connector on the outlet.

This device is regulated under FDA 510(k) clearance. It is designed for use in a clinical setting as a filter for infusion lines.

Other devices from Arteria Medical Science, Inc.

Questions

AI-generated answers, 21 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 Arteria Blood Filter?

    This device is designed for use in a clinical setting as a filter for infusion lines. It functions as a blood transfusion filter and drip chamber assembly to support safe fluid delivery.

  • What components are included in the Arteria Blood Filter assembly?

    The assembly consists of a filter and drip chamber integrated with flexible medical-grade tubing. It features a three-way stopcock valve with male and female Luer connections on the input side and a male Luer connector on the outlet.

  • What is the regulatory status of this device?

    The Arteria Blood Filter is regulated under FDA 510(k) clearance. It is classified under regulation number 880.5440 and falls under the General Hospital medical specialty.