Data / Medical devices / United States / Vein360
Vein360: FDA-registered device maker in Blue Ash, OH, United States, 4 510(k) clearances
Vein360 is registered with the FDA (registration 3015988948) in Blue Ash, OH, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 24, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015988948
- Address
- 4460 Lake Forest Dr STE 218, Blue Ash, OH, United States, 45242
- Owner or operator
- Vein360 (10061626)
- Roles
- Reprocessor
- First device listed
- November 4, 2019
- Registered through
- 2027
- Brand names listed
- Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter, Vein360 Reprocessed Visions PV14P Rx Digital IVUS Catheter (014P), Vein360 Reprocessed Visions PV14P Rx Digital IVUS Catheter (014R), Vein360 Reprocessed Visions PV18 Digital IVUS Catheter, Vein360 Reprocessed Visions PV35 Digital IVUS Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Reprocessor | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | 2 | Reprocessor | accessdata.fda.gov |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | 2 | Reprocessor | 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 |
|---|---|---|---|---|---|---|
| October 24, 2023 | K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | OWQ | Substantially Equivalent | Vein 360, LLC | accessdata.fda.gov |
| August 25, 2023 | K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | OWQ | Substantially Equivalent | Vein 360, LLC | accessdata.fda.gov |
| June 6, 2023 | K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | OWQ | Substantially Equivalent | Vein 360, LLC | accessdata.fda.gov |
| October 22, 2019 | K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | NUJ | Substantially Equivalent | Vein 360, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Reprocessed Intravascular Ultrasound Catheter
Updated October 24, 2023. 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.