510(k) K241576
- Device
- 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.
- 510(k) number
- K241576
- Product code
- OGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-26
- Date received
- 2024-06-03
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Plaque Morphology Evaluation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stephen Sum
- Address
- 28 Crosby Dr. Suite 100 Bedford MA US 01730 01730
FDA Registration Numbers#
- 3017654247
- 1061124
- 1220477
- 2245304
- 8043817
- 3015551113
Source Documents#
Other 510(k) Records For Product Code OGZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | 2019-04-12 |
| K163345 | TVC Imaging System, TVC Catheter | Infraredx, Inc. | 2017-06-21 |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-11-24 |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-04-23 |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2013-10-17 |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2013-03-15 |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2010-06-30 |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Infraredx, Inc. | 2008-04-25 |