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FDA 510(k)

CONCENTRIC EMBOLIC PEARLS

K-Number: K050470 · 2005-05-06

ApplicantConcentric Medical, Inc.
Decision Date2005-05-06
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONCENTRIC EMBOLIC PEARLS is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical, Inc.. It received FDA 510(k) clearance on 2005-05-06 under 510(k) number K050470. 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 CONCENTRIC EMBOLIC PEARLS?

CONCENTRIC EMBOLIC PEARLS is a medical device that received FDA 510(k) clearance on 2005-05-06. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K050470.

When did CONCENTRIC EMBOLIC PEARLS receive FDA 510(k) clearance?

CONCENTRIC EMBOLIC PEARLS received FDA 510(k) clearance on 2005-05-06, under 510(k) number K050470.

Who is the listed applicant for CONCENTRIC EMBOLIC PEARLS?

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

What is the FDA product code for CONCENTRIC EMBOLIC PEARLS?

The FDA product code for CONCENTRIC EMBOLIC PEARLS is KRD.

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Other records listing Concentric Medical, Inc. as applicant

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Related Devices (Code: 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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