FDA Product Code
FDA Product Code OGZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. | 2025-02-26 | Traditional | PDF ↗ |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | 2019-04-12 | Traditional | PDF ↗ |
| K163345 | TVC Imaging System, TVC Catheter | Infraredx, Inc. | 2017-06-21 | Traditional | PDF ↗ |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-04-23 | Traditional | PDF ↗ |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2013-10-17 | Traditional | PDF ↗ |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2013-03-15 | Traditional | PDF ↗ |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2010-06-30 | Traditional | PDF ↗ |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Infraredx, Inc. | 2008-04-25 | Traditional | PDF ↗ |
Product code OGZ · Class II · Cardiovascular. Data: openFDA.