K123108 is an FDA 510(k) clearance for the TVC IMAGING SYSTEM MODEL NIRS-MC7-70. This device is classified as a Catheter, Intravascular, Plaque Morphology Evaluation (Class II - Special Controls, product code OGZ).
Submitted by Infraredx, Inc. (Burlington, US). The FDA issued a Cleared decision on March 15, 2013, 163 days after receiving the submission on October 3, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. 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..
| 510(k) Number | K123108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2012 |
| Decision Date | March 15, 2013 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | OGZ - Catheter, Intravascular, Plaque Morphology Evaluation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| 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. |