Shiley Coronary Cardioplegia Adaptor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843542 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

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 Coronary Cardioplegia Adaptor used for?

  The Shiley Coronary Cardioplegia Adaptor is a vascular device designed for use in cardiovascular procedures to facilitate cardioplegia delivery during cardiac surgery. It is classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass.

• Is the Shiley Coronary Cardioplegia Adaptor single-use or reusable?

  The Shiley Coronary Cardioplegia Adaptor is intended for single-use in cardiopulmonary bypass applications during cardiovascular procedures. It should not be reused due to potential contamination risks and performance degradation.

• What is the regulatory status of the Shiley Coronary Cardioplegia Adaptor?

  The device is authorized under FDA 510(k) clearance K843542 with a product code DWF. It is a Class II device regulated under 870.4210, classified as substantially equivalent to predicate devices.

• How is the Shiley Coronary Cardioplegia Adaptor supplied?

  The Shiley Coronary Cardioplegia Adaptor is supplied by Shiley, Inc. It is designed for single-use in cardiopulmonary bypass applications during cardiovascular procedures, ensuring sterility and safety for each use.