Shiley Dispos. Cannula Fenestrated Low

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843729 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

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 purpose of the fenestrated design in the Shiley Disposable Cannula?

  The fenestrated design includes an opening that allows for increased airflow and helps permit the patient to breathe through the upper airway if desired, while also supporting the patient's ability to cough effectively.

• Is the Shiley Disposable Cannula Fenestrated Low reusable or single-use?

  This cannula is supplied as a single-use item and is not intended for reuse. It is designed to be discarded after one patient use to maintain hygiene and safety standards.

• What sizes are available for the Shiley Disposable Cannula Fenestrated Low?

  The device is available in various sizes as specified by the manufacturer, allowing clinicians to select the appropriate size for individual patient needs in anesthesiology settings.

• What is the regulatory status of the Shiley Disposable Cannula Fenestrated Low?

  This device is regulated under FDA 510K clearance with product code BTO, meaning it has been determined to be substantially equivalent to predicate devices already on the market.