Bjork-Shiley Aortic Graft Valve Prosth

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791225 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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 primary use of the Bjork-Shiley Aortic Graft Valve Prosthesis and how does it function in the body?

  The Bjork-Shiley Aortic Graft Valve Prosthesis is designed specifically for implantation in the aortic position to replace a damaged or diseased natural aortic valve. As a tilting-disk mechanical valve, it allows one-way blood flow while minimizing obstruction and backflow (regurgitation), effectively replicating the function of a healthy aortic valve.

• Is this device intended for reuse after a single surgical procedure, and if not, how should it be handled to maintain sterility?

  The Bjork-Shiley Aortic Graft Valve Prosthesis is intended for single-use only during surgical implantation. Since it is supplied sterile, it must be handled using strict sterile surgical instrument protocols to prevent contamination before and during use.

• Can this valve be safely used in patients who require MRI scans, and what precautions should be taken?

  Yes, the Bjork-Shiley Aortic Graft Valve Prosthesis is non-magnetic and MRI-safe when implanted. However, standard MRI imaging protocols should still be followed to avoid potential interference or complications, as even MRI-safe devices may interact with specific imaging parameters.

• What regulatory pathway was followed for this device’s approval, and under which category is it classified?

  The Bjork-Shiley Aortic Graft Valve Prosthesis was cleared through the FDA 510(k) pathway (K791225) and is classified under the cardiovascular device category for aortic valve replacement. It was determined to be *substantially equivalent* to a predicate device, as noted in the submission.

• Are there different sizes or models available for this valve, and how would a clinician determine the appropriate fit for a patient?

  While the provided data does not specify exact sizes or models, the Bjork-Shiley Aortic Graft Valve Prosthesis is designed for aortic valve replacement and would typically be selected based on the patient’s anatomical measurements and surgeon preference. Sizing is generally determined intraoperatively to ensure proper function and fit.