The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Makoto Intravascular Imaging System, Dualpro Ivus + Nirs Imaging Catheter.
| Device ID | K183599 |
| 510k Number | K183599 |
| Device Name: | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging 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 | 2018-12-26 |
| Decision Date | 2019-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857595006166 | K183599 | 000 |