Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
FDA 510(k) clearance K241576 · decided 2025-02-26
Clearance details
- K-number
- K241576
- Device name
- Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
- Applicant
- Infraredx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-03
- Decision date
- 2025-02-26
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- OGZ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599) | Infraredx, Inc. | 2019-04-12 |
| TVC Imaging System, TVC Catheter (K163345) | Infraredx, Inc. | 2017-06-21 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K141682) | Infraredx, Inc. | 2014-11-24 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897) | Infraredx, Inc. | 2014-04-23 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719) | Infraredx, Inc. | 2013-10-17 |
| TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (K123108) | Infraredx, Inc. | 2013-03-15 |
| LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (K093993) | Infraredx, Inc. | 2010-06-30 |
| INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (K072932) | Infraredx, Inc. | 2008-04-25 |
Recalls involving this device
No recalls on record reference this clearance.