Not Cleared Direct

DEN230069 - Mi-CHORD System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230069 · Lsi Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
256d
Days
Class 2
Risk

DEN230069 is an FDA 510(k) submission (not cleared) for the Mi-CHORD System. Classified as Artificial Chordae Tendineae Surgical Replacement System (product code SBK), Class II - Special Controls.

Submitted by Lsi Solutions, Inc. (Victor, US). The FDA issued a Not Cleared (DENG) decision on June 11, 2024 after a review of 256 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3490 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 256 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Lsi Solutions, Inc. devices

Submission Details

510(k) Number DEN230069 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2023
Decision Date June 11, 2024
Days to Decision 256 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics

Device Classification

Product Code SBK Artificial Chordae Tendineae Surgical Replacement System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3490
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.