FDA product code SBK: Artificial Chordae Tendineae Surgical Replacement System

SBK is the FDA product code for artificial chordae tendineae surgical replacement system. It is a Class II device, regulated under 21 CFR 870.3490 and reviewed by the Cardiovascular panel. Devices under SBK reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access.

Classification

Recalls for SBK devices

openFDA lists no recalls for product code SBK.

Frequently asked questions

What is FDA product code SBK?

SBK is the FDA product code for artificial chordae tendineae surgical replacement system. It is a Class II device, regulated under 21 CFR 870.3490 and reviewed by the Cardiovascular panel.

What device class is SBK?

Class II, regulation 21 CFR 870.3490. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SBK
• Run a recall and safety report across every SBK manufacturer
• Watch product code SBK for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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