SBKClass II

Artificial Chordae Tendineae Surgical Replacement System

21 CFR 870.3490 / Cardiovascular

SBK is the FDA product code for Artificial Chordae Tendineae Surgical Replacement System, a class II device type, regulated under 21 CFR 870.3490. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2024-06-11, and no recalls.

Classification record

Product code: SBK
Device name: Artificial Chordae Tendineae Surgical Replacement System
FDA 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.
Regulation: 21 CFR 870.3490
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code SBK

By decision year

1 clearance under product code SBK with a decision year between 2024 and 2024, 2024 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code SBK by decision year
Year	Clearances
2024	1

Applicants with the most clearances

Product code SBK

Applicants holding the most 510(k) clearances under product code SBK
Applicant	Clearances
Lsi Solutions Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Lsi Solutions Inc.

Recent clearances

Product code SBK

DEN230069Class IIMi-CHORD SystemLsi Solutions, Inc. / cleared 2024-06-11

Recent recalls

Product code SBK

FDA records show no recalls under product code SBK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)