K241576 is an FDA 510(k) clearance for the Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i). This device is classified as a Catheter, Intravascular, Plaque Morphology Evaluation (Class II - Special Controls, product code OGZ).
Submitted by Infraredx, Inc. (Bedford, US). The FDA issued a Cleared decision on February 26, 2025, 268 days after receiving the submission on June 3, 2024.
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 | K241576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2024 |
| Decision Date | February 26, 2025 |
| Days to Decision | 268 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. |