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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2018-04-19 under 510(k) 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. The listed applicant is Boston Scientific. The 510(k) number is K180102.

When did Embozene Color-Advanced Microspheres receive FDA 510(k) clearance?

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

Who is the listed applicant for Embozene Color-Advanced Microspheres?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: NOY)

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.

K203276Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)Biocompatibles UK Ltd (Part of Boston Scientific CorporationK192684HydroPearl MicrospheresMicroVention, Inc.

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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