TVC Imaging System, TVC Insight Catheter
FDA 510(k) K133897 · Infraredx, Inc.
510(k) numberK133897
Submission
- Device name
- TVC Imaging System, TVC Insight Catheter
- Applicant
- Infraredx, Inc.
Burlington, MA, US - Received
- December 20, 2013
- Decision date
- April 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OGZ – Catheter, Intravascular, Plaque Morphology Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code OGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging…OGZ · Traditional | Infraredx, Inc. | 02/26/2025SE |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterOGZ · Traditional | Infraredx, Inc. | 04/12/2019SE |
| K163345 | TVC Imaging System, TVC CatheterOGZ · Traditional | Infraredx, Inc. | 06/21/2017SE |
| K141682 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | Infraredx, Inc. | 11/24/2014SE |
| K130719 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | Infraredx, Inc. | 10/17/2013SE |
| K123108 | TVC Imaging System Model NIRS-MC7-70OGZ · Traditional | Infraredx, Inc. | 03/15/2013SE |
| K093993 | Lipiscan Ivus Imaging System Model NIRS-MC7-70OGZ · Traditional | Infraredx, Inc. | 06/30/2010SE |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5OGZ · Traditional | Infraredx, Inc. | 04/25/2008SE |
More from Infraredx, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging…OGZ · Traditional | 02/26/2025SE |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging…IYO · Traditional | 12/07/2021SE |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterOGZ · Traditional | 04/12/2019SE |
| K163345 | TVC Imaging System, TVC CatheterOGZ · Traditional | 06/21/2017SE |
| K141682 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | 11/24/2014SE |
| K130719 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | 10/17/2013SE |
| K123108 | TVC Imaging System Model NIRS-MC7-70OGZ · Traditional | 03/15/2013SE |
| K093993 | Lipiscan Ivus Imaging System Model NIRS-MC7-70OGZ · Traditional | 06/30/2010SE |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5OGZ · Traditional | 04/25/2008SE |
| K052908 | Intraredx Nir Imaging System, Model MC-5DQO · Traditional | 06/23/2006SE |
Questions and answers
When was TVC Imaging System, TVC Insight Catheter cleared by the FDA?
TVC Imaging System, TVC Insight Catheter (K133897) received a 510(k) decision of Substantially Equivalent on April 23, 2014, 124 days after the submission was received.
What is the product code of K133897?
The FDA product code is OGZ – Catheter, Intravascular, Plaque Morphology Evaluation, a Class II (moderate risk) device regulated under 21 CFR 870.1200.