FDA.report

510(k) K250960

Device
DUO Microcatheter
Applicant
Rev Neuro, LLC
510(k) number
K250960
Product code
QJP
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-08
Date received
2025-03-31
Regulation
870.1250
Classification name
Catheter, Percutaneous, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Shiva Ardakani
Address
7060 Koll Center Pkwy. Suite #300 Pleasonton CA US 94566 94566

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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