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Venous Reservoir

by Shiley, Inc. 510(k)

Active United States

510(k) K832924

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832924 Date31 Oct 1983ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTN
Device Class
Class II
Regulation
21 CFR Part 870.4400
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

A venous reservoir is a device used to collect and store blood during cardiopulmonary bypass procedures. It functions as a blood reservoir in extracorporeal circulation systems, allowing for the temporary holding of venous blood returned from the patient before it is pumped through the oxygenator and back into the arterial system.

This device is supplied as a reusable component for use in cardiovascular surgical settings. It is classified as a Class II medical device under FDA regulation 870.4400 with product code DTN, and has received FDA 510(k) clearance (K832924) as substantially equivalent to a legally marketed device. The device is manufactured by Shiley, Inc. and is intended for use in cardiopulmonary bypass systems under special controls.

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Questions

AI-generated answers, 22 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 venous reservoir used for?

    The venous reservoir is used to collect and store blood during cardiopulmonary bypass procedures, functioning as a temporary holding chamber for venous blood returned from the patient before it is pumped through the oxygenator and back into the arterial system.

  • Is the venous reservoir reusable or single-use?

    The venous reservoir is supplied as a reusable component for use in cardiovascular surgical settings, meaning it is designed to be cleaned, sterilized, and used multiple times according to the manufacturer's reprocessing instructions.

  • What regulatory pathway was used for this venous reservoir?

    The device received FDA 510(k) clearance (K832924) as substantially equivalent to a legally marketed device, following a traditional clearance pathway under FDA regulation 870.4400 with product code DTN.