FDA.report

510(k) K250310

Device
VIKING™ Fixed Curve Diagnostic Catheter
Applicant
Boston Scientific Corporation
510(k) number
K250310
Product code
DRF
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-27
Date received
2025-02-03
Regulation
870.1220
Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
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
Oliver Buttleman
Address
4100 Hamline Ave. N St Paul MN US 55112 55112

FDA Registration Numbers

Source Documents

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

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