Arterial Embolectomy Catheter (Modified)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790838 ↗

FDA Product Code

DXE

Device Class

Class II

Regulation

21 CFR Part 870.5150

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 Arterial Embolectomy Catheter (Modified) used for?

  The Arterial Embolectomy Catheter (Modified) is a Class II cardiovascular catheter designed specifically for embolectomy procedures. It is used to remove emboli from arterial vessels, which helps restore blood flow to affected areas that have been compromised by blockages.

• How is the Arterial Embolectomy Catheter supplied and is it single-use?

  The device is supplied by Shiley, Inc. and is intended for single-use in clinical settings. While specific sterility information is not provided in the available data, the catheter is designed for one-time use to ensure patient safety and device performance.

• What is the regulatory status of this device?

  The Arterial Embolectomy Catheter (Modified) has FDA 510(k) clearance with number K790838. It is classified under product code DXE and regulated under FDA regulation number 870.5150. The device was determined to be substantially equivalent to predicate devices.

• Are there different sizes or models available for this catheter?

  The available data does not specify different sizes or models for the Arterial Embolectomy Catheter (Modified). The device is described as a single product type, though specific dimensional information would need to be obtained directly from the manufacturer for clinical application details.