SBK · Class II · 21 CFR 870.3490

FDA Product Code SBK: Artificial Chordae Tendineae Surgical Replacement System

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.

Leading manufacturers include Lsi Solutions, Inc..

1
Total
0
Cleared
256d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Artificial Chordae Tendineae Surgical Replacement System Devices (Product Code SBK)

1 devices
1–1 of 1
Not Cleared Jun 11, 2024
Mi-CHORD System
DEN230069
Lsi Solutions, Inc.
Cardiovascular · 256d

About Product Code SBK - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SBK since 2024, with 0 receiving FDA clearance (average review time: 256 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SBK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →