VEIN360

FDA Device Registration & Listing · Blue Ash, OH, US · Registration 3015988948

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015988948
FEI Number
3015988948
Entity Name
VEIN360
City/State/Country
Blue Ash, OH, US
Establishment Address
4460 Lake Forest Dr, STE 218, Blue Ash, OH 45242, US
Establishment Type(s)
Reprocess Single-Use Device
Owner / Operator
Vein360 (Owner Number: 10061626)
Owner / Operator Contact Address
4460 LAKE FOREST DR, STE 218, Cincinnati, OH 45242, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232584
PMA Number
N/A

All Registered Proprietary Names

Vein360 Reprocessed Visions PV18 Digital IVUS Catheter Vein360 Reprocessed Visions PV35 Digital IVUS Catheter Vein360 Reprocessed Visions PV14P Rx Digital IVUS Catheter (014R) Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter Vein360 Reprocessed Visions PV14P Rx Digital IVUS Catheter (014P)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2023-10-05
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2023-07-05
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2023-10-31

Official Correspondent

Suzanne Meyer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vein360
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K232130 Surgical Instrument Services and Savings, Inc. Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter 2023-12-15
K230934 ABBOTT MEDICAL ViewFlex™ Eco Reprocessed ICE Catheter 2023-05-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015988948. Last updated year: 2026. Please use registration number 3015988948 when referencing this establishment in official correspondence.
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