Infraredx, Inc.
FDA Regulatory Profile
Infraredx, Inc. appears in FDA public data with 1 recall, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0940-2017, Class II) was initiated on December 15, 2016. Its most recent 510(k) clearance was granted on February 26, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0940-2017 | Class II | TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patient | December 15, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC | February 26, 2025 |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C | December 7, 2021 |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | April 12, 2019 |
| K163345 | TVC Imaging System, TVC Catheter | June 21, 2017 |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | November 24, 2014 |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | April 23, 2014 |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | October 17, 2013 |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | March 15, 2013 |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | June 30, 2010 |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | April 25, 2008 |
| K052908 | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 | June 23, 2006 |