This page includes the latest FDA filings for Infraredx Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Infraredx Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3015551113 |
| FEI Number | 3015551113 |
| Name | INFRAREDX, INC. |
| Owner & Operator | Infraredx, Inc. |
| Contact Address | 28 Crosby Drive, Suite 100 Bedford MA 01730 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 28 Crosby Drive, Suite 100 Bedford, MA 01730 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| INFRAREDX, INC. | Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit TVC-E195-42 | 2022-11-21 |
| INFRAREDX, INC. | Makoto Integrated Intravascular Imaging System™ TVC-MC10i | 2022-11-21 |
| INFRAREDX, INC. | GM-30 Accessory Kit | 2022-02-11 |
| INFRAREDX, INC. | GM-30 Accessory Kit | 2022-02-11 |
| INFRAREDX, INC. | GM-30 Accessory Kit | 2022-02-11 |
| INFRAREDX, INC. | GM-30 Accessory Kit | 2022-02-11 |
| INFRAREDX, INC. | GM-30 Inflation Device GM-30NL | 2021-03-15 |
| INFRAREDX, INC. | GM-30 Inflation Device GM-30NF | 2021-03-15 |
| INFRAREDX, INC. | GM-30 Inflation Device GM-30N | 2021-03-15 |
| INFRAREDX, INC. | OKAY® II Y-Connector Set with Extension Tube | 2020-03-05 |
| INFRAREDX, INC. | OKAY® II Y-Connector | 2020-03-05 |
| INFRAREDX, INC. | OKAY® II Y-Connector Set | 2020-03-05 |
| INFRAREDX, INC. | TVC Controller Sterile Barrier TVC-MC8-B1 | 2020-02-06 |
Infraredx, Inc. | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | 2019-04-12 |
| INFRAREDX, INC. | Dualpro™ IVUS+NIRS Imaging Catheter Kit TVC-C195-42 | 2019-03-21 |
| INFRAREDX, INC. | TVC Insight XB™ TVC-C195-32 | 2019-03-21 |
| INFRAREDX, INC. | TVC Insight™ TVC-C195-22 | 2019-03-21 |
| INFRAREDX, INC. | TVC Insight™ TVC-C195-20 | 2019-03-21 |
| INFRAREDX, INC. | TVC Integrated Imaging System™ TVC-MC9i | 2018-11-20 |
| INFRAREDX, INC. | Makoto Intravascular Imaging System™ TVC-MC10 | 2018-11-20 |
| INFRAREDX, INC. | TVC Imaging System™ TVC-MC9 | 2018-11-20 |
| INFRAREDX, INC. | TVC Imaging System™ TVC-MC8 | 2018-11-20 |
| INFRAREDX, INC. | TVC Imaging System™ TVC-MC8 | 2018-11-20 |
INFRAREDX, INC. | Makoto Intravascular Imaging System | 2017-10-11 |
INFRAREDX, INC. | Dualpro IVUS+NIRS Imaging Catheter | 2017-10-11 |
INFRAREDX, INC. | Makoto Intravascular Imaging System | 2017-10-11 |
INFRAREDX, INC. | Dualpro IVUS+NIRS Imaging Catheter | 2017-10-11 |
Infraredx, Inc. | TVC Imaging System, TVC Catheter | 2017-06-21 |
Infraredx, Inc. | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | 2014-11-24 |
Infraredx, Inc. | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | 2014-04-23 |
Infraredx, Inc. | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | 2013-10-17 |
Infraredx, Inc. | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | 2013-03-15 |
Infraredx, Inc. | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | 2010-06-30 |
Infraredx, Inc. | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | 2008-04-25 |
Infraredx, Inc. | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 | 2006-06-23 |
| NCAGE Code | 5AZX3 | INFRAREDX, INC. |
| CAGE Code | 5AZX3 | INFRAREDX, INC. |
| S.A.M. Registration | 5AZX3 [124065421] | INFRAREDX, INC. |
| DUNS | 124065421 | Infraredx, Inc. |
| SEC | 0001111406 | INFRAREDX INC of DELAWARE |
| SEC | 0001303787 | Infraredx Inc |