OGZ
9 FDA 510(k) clearances · Product code
188 daysmedian time to decision
268 days90th percentile
9clearances measured
FDA profile
- Official device name
- Catheter, Intravascular, Plaque Morphology Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- FDA definition
- Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (K241576) | Infraredx, Inc. | 2025-02-26 |
| Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599) | Infraredx, Inc. | 2019-04-12 |
| TVC Imaging System, TVC Catheter (K163345) | Infraredx, Inc. | 2017-06-21 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K141682) | Infraredx, Inc. | 2014-11-24 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897) | Infraredx, Inc. | 2014-04-23 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719) | Infraredx, Inc. | 2013-10-17 |
| TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (K123108) | Infraredx, Inc. | 2013-03-15 |
| LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (K093993) | Infraredx, Inc. | 2010-06-30 |
| INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (K072932) | Infraredx, Inc. | 2008-04-25 |
Track OGZ automatically
Every clearance here is in the API, with alerts when new ones post.