The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Tvc Imaging System, Tvc Insight Catheter.
| Device ID | K133897 |
| 510k Number | K133897 |
| Device Name: | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER |
| Classification | Catheter, Intravascular, Plaque Morphology Evaluation |
| Applicant | Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 |
| Contact | Steven J Chartier |
| Correspondent | Steven J Chartier Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 |
| Product Code | OGZ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857595006418 | K133897 | 000 |
| 00857595006401 | K133897 | 000 |