K163345 is an FDA 510(k) clearance for the TVC Imaging System, TVC Catheter. 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 June 21, 2017, 204 days after receiving the submission on November 29, 2016.
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 | K163345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2016 |
| Decision Date | June 21, 2017 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| 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. |