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FDA 510(k)

Embozene Color-Advanced Microspheres

K-Number: K180102 · 2018-04-19

ApplicantBoston Scientific
Decision Date2018-04-19
Product CodeNOY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Embozene Color-Advanced Microspheres is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2018-04-19 under approval number K180102. The device is classified under product code NOY. It was reviewed by the GU 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 2018-04-19. It is manufactured by Boston Scientific. The 510(k) number is K180102.

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

Embozene Color-Advanced Microspheres received FDA 510(k) clearance on 2018-04-19, under approval number K180102.

What company makes Embozene Color-Advanced Microspheres?

Embozene Color-Advanced Microspheres is manufactured by Boston Scientific.

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

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

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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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