Modified Coronary Cardioplegia Adaptor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854640 ↗

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 Modified Coronary Cardioplegia Adaptor used for?

  The Modified Coronary Cardioplegia Adaptor is a catheter, cannula, and tubing device used in vascular cardiopulmonary bypass procedures, as stated in its description, to support cardiac surgery by delivering cardioplegic solution to arrest the heart during bypass.

• Who manufactures the Modified Coronary Cardioplegia Adaptor and what is its product code?

  The Modified Coronary Cardioplegia Adaptor is manufactured by Shiley, Inc. and is assigned the product code DWF, which identifies the device type within the FDA’s product classification system for cardiovascular devices.

• When did the Modified Coronary Cardioplegia Adaptor receive FDA clearance and under what regulation?

  The Modified Coronary Cardioplegia Adaptor received FDA 510(k) clearance (K854640) on February 10, 1986, under regulation number 870.4210, which governs vascular cardiopulmonary bypass devices, based on a determination of substantial equivalence to a predicate.