Cleared Special

ONCOZENE Microspheres

K242794 · Varian Medical Systems, Inc. · Cardiovascular
Oct 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242794 is an FDA 510(k) clearance for the ONCOZENE Microspheres, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 16, 2024, 30 days after receiving the submission on September 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K242794 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2024
Decision Date October 16, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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