OGZ · Catheter, Intravascular, Plaque Morphology Evaluation
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | OGZ |
|---|---|
| Device Name | Catheter, Intravascular, Plaque Morphology Evaluation |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Feb 26, 2025 | SESE |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | Apr 12, 2019 | SESE |
| K163345 | TVC Imaging System, TVC Catheter | Infraredx, Inc. | Jun 21, 2017 | SESE |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | Nov 24, 2014 | SESE |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | Apr 23, 2014 | SESE |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | Oct 17, 2013 | SESE |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | Mar 15, 2013 | SESE |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | Jun 30, 2010 | SESE |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Infraredx, Inc. | Apr 25, 2008 | SESE |
Top Applicants
- Infraredx, Inc. — 9 clearances
