The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Tvc Imaging System, Tvc Catheter.
| Device ID | K163345 |
| 510k Number | K163345 |
| Device Name: | TVC Imaging System, TVC Catheter |
| Classification | Catheter, Intravascular, Plaque Morphology Evaluation |
| Applicant | Infraredx, Inc. 34 Third Avenue Burlington, MA 01803 |
| Contact | Stephen Sum |
| Correspondent | Stephen Sum Infraredx, Inc. 34 Third Avenue 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 | 2016-11-29 |
| Decision Date | 2017-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857595006432 | K163345 | 000 |