Shiley Cardiotomy Reservoir W/Filter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842711 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

See all devices from Shiley, Inc. →

• What is the primary function of the Shiley Cardiotomy Reservoir?

  This device is designed to function as a blood reservoir component within a cardiopulmonary bypass circuit, assisting in the management of blood during procedures.

• How is this device classified for regulatory purposes?

  The Shiley Cardiotomy Reservoir is classified as a Class II medical device under regulation number 870.4400 and product code DTN, which pertains to cardiopulmonary bypass blood reservoirs.

• Has this device received regulatory clearance?

  Yes, the device received FDA 510(k) clearance under reference number K842711, confirming it was found to be substantially equivalent to other legally marketed devices.