Shiley M2000 Membrane Oxygenator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833253 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

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 Shiley M2000 Membrane Oxygenator used for?

  The Shiley M2000 Membrane Oxygenator is intended for use in cardiovascular procedures as a cardiopulmonary bypass oxygenator, based on its classification under product code DTZ and regulation number 870.4350, which defines its role in supporting oxygen and carbon dioxide exchange during bypass surgery.

• When did the Shiley M2000 Membrane Oxygenator receive FDA clearance?

  The device received FDA 510(k) clearance under submission K833253 on December 1, 1983, after a traditional submission was received on September 20, 1983, and was determined to be substantially equivalent to a legally marketed predicate device.

• Who manufactures the Shiley M2000 Membrane Oxygenator and where is it located?

  The Shiley M2000 Membrane Oxygenator is manufactured by Shiley, Inc., with the applicant address listed as 803 N. Front St. Suite 3, McHenry, IL 60050, United States, as recorded in the FDA registration and device listing data.