Catheter, Intravascular, Plaque Morphology Evaluation
FDA product code OGZ · Class II (moderate risk) · 21 CFR 870.1200 · Cardiovascular
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.
9510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging…OGZ · Traditional | Infraredx, Inc. | 02/26/2025SE |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterOGZ · Traditional | Infraredx, Inc. | 04/12/2019SE |
| K163345 | TVC Imaging System, TVC CatheterOGZ · Traditional | Infraredx, Inc. | 06/21/2017SE |
| K141682 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | Infraredx, Inc. | 11/24/2014SE |
| K133897 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | Infraredx, Inc. | 04/23/2014SE |
| K130719 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | Infraredx, Inc. | 10/17/2013SE |
| K123108 | TVC Imaging System Model NIRS-MC7-70OGZ · Traditional | Infraredx, Inc. | 03/15/2013SE |
| K093993 | Lipiscan Ivus Imaging System Model NIRS-MC7-70OGZ · Traditional | Infraredx, Inc. | 06/30/2010SE |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5OGZ · Traditional | Infraredx, Inc. | 04/25/2008SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0940-2017 Class II | TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary…Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases… | Infraredx, Inc. | 12/15/2016Terminated |