FDA 510(k)

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

K-Number: K100663 · 2010-04-16

Decision Date2010-04-16

Product CodeNAJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2010-04-16 under 510(k) number K100663. The device is classified under product code NAJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321?

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 is a medical device that received FDA 510(k) clearance on 2010-04-16. The listed applicant is Boston Scientific Corporation. The 510(k) number is K100663.

When did CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 receive FDA 510(k) clearance?

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 received FDA 510(k) clearance on 2010-04-16, under 510(k) number K100663.

Who is the listed applicant for CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321?

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

What is the FDA product code for CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321?

The FDA product code for CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 is NAJ.

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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.