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FDA 510(k)

Embozene Color-Advanced Microspheres

K-Number: K242608 · 2025-01-17

ApplicantVarian Medical Systems, Inc.
Decision Date2025-01-17
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Embozene Color-Advanced Microspheres is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K242608. 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 Embozene Color-Advanced Microspheres?

Embozene Color-Advanced Microspheres is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K242608.

When was Embozene Color-Advanced Microspheres approved by the FDA?

Embozene Color-Advanced Microspheres received FDA 510(k) clearance on 2025-01-17, under approval number K242608.

What company makes Embozene Color-Advanced Microspheres?

Embozene Color-Advanced Microspheres is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Embozene Color-Advanced Microspheres?

The FDA product code for Embozene Color-Advanced Microspheres is KRD.

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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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