FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
K Number: K241576
·
Decision Feb 26, 2025
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
8
Applicant Total
11
Review Days
268
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Basic Information
- Device Name
- Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
- K Number
- K241576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infraredx, Inc.
- Date Received
- June 3, 2024
- Decision Date
- February 26, 2025
- Product Code
- OGZ
- 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 |
|---|---|---|---|
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OGZ), ordered by most recent decision date.
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TVC Imaging System, TVC Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Infraredx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | Dec 7, 2021 | Substantially Equivalent |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Apr 12, 2019 | Substantially Equivalent |
| K163345 | TVC Imaging System, TVC Catheter | Jun 21, 2017 | Substantially Equivalent |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Nov 24, 2014 | Substantially Equivalent |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Apr 23, 2014 | Substantially Equivalent |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Oct 17, 2013 | Substantially Equivalent |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Mar 15, 2013 | Substantially Equivalent |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Jun 30, 2010 | Substantially Equivalent |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Apr 25, 2008 | Substantially Equivalent |
| K052908 | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 | Jun 23, 2006 | Substantially Equivalent |