Arterial Embolectomy Catheter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K840198 ↗

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

• Shiley Femoral Arterial Cannula

  Class II

  FDA 510(k) K881072 Active Cleared 31 May 1988

See all devices from Shiley, Inc. →

• What is the primary clinical purpose of the Arterial Embolectomy Catheter, and where is it typically used?

  The Arterial Embolectomy Catheter is designed to remove thromboembolic material from peripheral arteries, helping restore blood flow during acute ischemic events like peripheral artery occlusion or embolism. It is intended for use in controlled clinical settings such as operating rooms or catheterization labs, where aseptic techniques are standard.

• Is the Arterial Embolectomy Catheter reusable, or is it meant for single-use only?

  The device is explicitly supplied as a single-use catheter, meaning it is intended for one-time use only. This aligns with standard medical practice for maintaining sterility and reducing infection risks during procedures.

• What regulatory pathway was followed for the FDA clearance of this device, and what class does it belong to?

  The Arterial Embolectomy Catheter received FDA clearance through a 510(k) submission, classified as a Class II device under product code DXE. The clearance was granted as substantially equivalent to a predicate device, with the decision made by the FDA’s Cardiovascular (CV) Advisory Committee in 1984.

• Are multiple sizes or models of this catheter available, and how would a clinician determine the correct fit?

  The data lists multiple FEI numbers (e.g., 1000138054, 3005747797), which typically correspond to different sizes or configurations of the catheter. While exact sizing details aren’t provided, clinicians would rely on manufacturer documentation or procedural guidelines to select the appropriate size based on patient anatomy and the specific arterial site being treated.

• How should the Arterial Embolectomy Catheter be stored, and are there any special handling instructions?

  As a sterile, single-use device, the catheter should be stored in its original packaging until use, following the manufacturer’s instructions for shelf life and environmental conditions (e.g., temperature, humidity). Since it’s intended for aseptic procedures, storage should protect it from contamination until deployment in the operating room or catheterization lab.