K133897 is an FDA 510(k) clearance for the TVC IMAGING SYSTEM, TVC INSIGHT 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 April 23, 2014, 124 days after receiving the submission on December 20, 2013.
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 | K133897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2013 |
| Decision Date | April 23, 2014 |
| Days to Decision | 124 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. |