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Chest Drainage Pack, CDP-1000

by Gish Biomedical, Inc.

510(k) K861103

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 NumberK861103 Date28 May 1986ClearedStatusActive

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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
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 Chest Drainage Pack, CDP-1000 is a catheter, cannula and tubing device for vascular, cardiopulmonary bypass applications. It is classified under product code DWF and device class II with special controls.

The device received FDA 510(k) clearance K861103 on May 28, 1986, determined to be substantially equivalent. It is manufactured by Gish Biomedical, Inc. in Santa Ana, California, and is intended for use in cardiovascular procedures as indicated by the advisory committee classification.

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See all devices from Gish Biomedical, Inc. →

Questions

AI-generated answers, 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.

  • What is the Chest Drainage Pack, CDP-1000 used for?

    The Chest Drainage Pack, CDP-1000 is intended for use in vascular and cardiopulmonary bypass procedures as a catheter, cannula and tubing device, based on its classification under product code DWF and its FDA 510(k) clearance for cardiovascular applications.

  • How is the Chest Drainage Pack, CDP-1000 supplied and is it sterile?

    The device data does not specify sterility, single-use status, or packaging details for the Chest Drainage Pack, CDP-1000; therefore, no information about its supply format or sterility can be derived from the provided data.

  • What sizes or models are available for the Chest Drainage Pack, CDP-1000?

    The device data only identifies one model: CDP-1000. No additional sizes, variants, or model numbers are listed in the specifications for this specific device.

  • What regulatory pathway was used for the Chest Drainage Pack, CDP-1000?

    The Chest Drainage Pack, CDP-1000 received FDA 510(k) clearance through the traditional pathway, with clearance number K861103 granted on May 28, 1986, based on a determination of substantial equivalence.