510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230069Unknown

Mi-CHORD System

Lsi Solutions Inc., Victor NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN230069 is the FDA 510(k) clearance record for Mi-CHORD System, a class II device, cleared for Lsi Solutions, Inc. on under FDA product code SBK (Artificial Chordae Tendineae Surgical Replacement System). FDA's definition for product code SBK 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...". FDA records list 14 510(k) clearances for Lsi Solutions, Inc., from to . As of , FDA records show no recalls naming DEN230069.

Clearance record

Decision date
Received
(256 days to decision)
Product code
SBK Artificial Chordae Tendineae Surgical Replacement System
Regulation
21 CFR 870.3490
Device class
Class II
Review panel
Cardiovascular
Applicant
Lsi Solutions, Inc. 7796 Victor-Mendon Rd., Victor NY
Third party review
No

Clearances, product code SBK

Trailing 12 months

FDA records hold no clearances under product code SBK in the trailing twelve months.

FDA records show no clearances under product code SBK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260