OGZ — Catheter, Intravascular, Plaque Morphology Evaluation Class II
Classification Details
- Product Code
- OGZ
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241576 | infraredx | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS I | February 26, 2025 |
| K183599 | infraredx | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | April 12, 2019 |
| K163345 | infraredx | TVC Imaging System, TVC Catheter | June 21, 2017 |
| K141682 | infraredx | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | November 24, 2014 |
| K133897 | infraredx | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | April 23, 2014 |
| K130719 | infraredx | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | October 17, 2013 |
| K123108 | infraredx | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | March 15, 2013 |
| K093993 | infraredx | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | June 30, 2010 |
| K072932 | infraredx | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | April 25, 2008 |