K130719 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 October 17, 2013, 213 days after receiving the submission on March 18, 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 | K130719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2013 |
| Decision Date | October 17, 2013 |
| Days to Decision | 213 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. |