FDA 510(k)

CODMAN HAKIM MICRO II VALVE

K-Number: K091346 · 2009-06-02

Decision Date2009-06-02

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN HAKIM MICRO II VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2009-06-02 under 510(k) number K091346. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN HAKIM MICRO II VALVE?

CODMAN HAKIM MICRO II VALVE is a medical device that received FDA 510(k) clearance on 2009-06-02. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K091346.

When did CODMAN HAKIM MICRO II VALVE receive FDA 510(k) clearance?

CODMAN HAKIM MICRO II VALVE received FDA 510(k) clearance on 2009-06-02, under 510(k) number K091346.

Who is the listed applicant for CODMAN HAKIM MICRO II VALVE?

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

What is the FDA product code for CODMAN HAKIM MICRO II VALVE?

The FDA product code for CODMAN HAKIM MICRO II VALVE is JXG.

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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.