Data / Medical devices / United States / Nipro Vascular Innovations Americas, Inc.
Nipro Vascular Innovations Americas, Inc.: FDA-registered device maker in Bedford, MA, United States, 1 510(k) clearance
Nipro Vascular Innovations Americas, Inc. is registered with the FDA (registration 3015551113) in Bedford, MA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 26, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015551113
- Address
- 28 Crosby Drive, Suite 100, Bedford, MA, United States, 01730
- Owner or operator
- Nipro Vascular Innovations Americas, Inc. (10025766)
- Roles
- Manufacturer
- First device listed
- March 26, 2025
- Registered through
- 2027
- Brand names listed
- Clarispro HD-IVUS Imaging Catheter (TVC-E195-42), Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42), Makoto Intravascular Imaging System (TVC-MC10/TVC-MC10i)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Plaque Morphology Evaluation | OGZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2025 | K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | OGZ | Substantially Equivalent | Infraredx, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2016 | 76014 | Class II | Terminated | TVC Imaging System model TVC-MC9, for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously | Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Catheter, Intravascular, Plaque Morphology Evaluation
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated February 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.