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Shiley 3L Cardf Plus

by Shiley, Inc. 510(k)

Active United States

510(k) K832811

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832811 Date20 Sep 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  • Withdrawn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
DTP
Device Class
Class II
Regulation
21 CFR Part 870.4230
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Shiley 3L Cardf Plus is a Defoamer for Cardiopulmonary Bypass, classified under FDA product code DTP. This device is designed to remove air and foam from blood during cardiopulmonary bypass procedures, ensuring optimal oxygenation and circulation by eliminating entrapped gas and bubbles that could compromise patient safety.

Supplied as a single-use item, the Shiley 3L Cardf Plus is intended for use in sterile surgical environments during cardiac surgeries. It is regulated under FDA 510(k) clearance (K832811) and falls under the cardiovascular medical specialty, adhering to regulatory standards for defoamers in cardiopulmonary applications. The device is manufactured by Shiley, Inc., and its specifications align with FDA classification as a Class II medical device.

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