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— 510(k) K232584
Substantially EquivalentVein 360, LLC
FDA 510(k) clearance K232584 for 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, Substantially Equivalent on 2023-10-24. Applicant: Vein 360, LLC. Device class: 2.
Clearance details
- Applicant
- Vein 360, LLC
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Blue Ash, OH, US
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More clearances from Vein 360, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.