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510(k) DEN230069

Mi-CHORD System by Lsi Solutions, Inc. — Product Code SBK

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 11, 2024
Date Received
September 29, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Artificial Chordae Tendineae Surgical Replacement System
Device Class
Class II
Regulation Number
870.3490
Review Panel
CV
Submission Type

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.

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  • K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
  • K163639 — LS-5 ePTFE Suture (June 2, 2017)
  • K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (July 13, 2012)
  • K100593 — SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND AC (October 13, 2010)
  • K040232 — LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5 (March 1, 2004)
  • K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS (June 18, 2003)
  • K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT (March 24, 2003)