FDA 510(k)

MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047

K-Number: K091961 · 2009-07-30

Decision Date2009-07-30

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 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 2009-07-30 under 510(k) number K091961. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047?

MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K091961.

When did MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 receive FDA 510(k) clearance?

MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 received FDA 510(k) clearance on 2009-07-30, under 510(k) number K091961.

Who is the listed applicant for MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047?

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 MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047?

The FDA product code for MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 is DQO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.