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K242794

ONCOZENE Microspheres

510(k) number
K242794
Device name
ONCOZENE Microspheres
Applicant
Varian Medical Systems, Inc. CA · US
Product code
KRD — Device, Vascular, For Promoting Embolization
Decision date
2024-10-16
Date received
2024-09-16
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K242794.pdf

Official FDA record: K242794
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.