Modified Shiley Femoral Arterial Cannula

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884393 ↗

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 Shiley Femoral Arterial Cannula used for?

  The Modified Shiley Femoral Arterial Cannula is a vascular catheter used in cardiopulmonary bypass procedures. It is designed as an arterial cannula with an angled shoulder that limits insertion depth into the artery and forms a seal, and includes suture flaps for skin attachment and a stylet with a stop to prevent blood flow between the cannula and stylet while permitting clamping.

• How is the Modified Shiley Femoral Arterial Cannula supplied?

  The Modified Shiley Femoral Arterial Cannula is supplied by Shiley, Inc. from their address at 17600 Gillette Ave., P.O. Box 19503, Irvine, CA 92714, United States.

• Is the Modified Shiley Femoral Arterial Cannula sterile and for single use?

  The device data does not specify whether the Modified Shiley Femoral Arterial Cannula is sterile or intended for single use or reuse. This information is not provided in the authorization or specifications sections.

• What regulatory pathway was used for the Modified Shiley Femoral Arterial Cannula?

  The Modified Shiley Femoral Arterial Cannula received FDA 510(k) clearance (K884393) on December 27, 1988, and is classified as a Class II medical device under regulation number 870.4210.