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FDA 510(k)

ONCOZENE Microspheres

K-Number: K242794 · 2024-10-16

ApplicantVarian Medical Systems, Inc.
Decision Date2024-10-16
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ONCOZENE Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K242794. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONCOZENE Microspheres?

ONCOZENE Microspheres is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K242794.

When did ONCOZENE Microspheres receive FDA 510(k) clearance?

ONCOZENE Microspheres received FDA 510(k) clearance on 2024-10-16, under 510(k) number K242794.

Who is the listed applicant for ONCOZENE Microspheres?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONCOZENE Microspheres?

The FDA product code for ONCOZENE Microspheres is KRD.

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Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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