FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Mi-CHORD System
K Number: DEN230069
·
Decision Jun 11, 2024
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
6
Review Days
256
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Basic Information
- Device Name
- Mi-CHORD System
- K Number
- DEN230069
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.3490
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Lsi Solutions, Inc.
- Date Received
- September 29, 2023
- Decision Date
- June 11, 2024
- Product Code
- SBK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SBK | Artificial Chordae Tendineae Surgical Replacement System | FDA class 2 | Cardiovascular |
Other Clearances by Lsi Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222783 | MD Mattress Suture Placement Device | Jan 12, 2024 | Substantially Equivalent |
| K202551 | Cor-Knot Micro | Jun 24, 2021 | Substantially Equivalent |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Nov 24, 2020 | Substantially Equivalent |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | Jul 13, 2012 | Substantially Equivalent |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME | Oct 13, 2010 | Substantially Equivalent |