FDA 510(k)

ANCHORWIRE GUIDEWIRE

K-Number: K111288 · 2011-08-02

Decision Date2011-08-02

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANCHORWIRE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K111288. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCHORWIRE GUIDEWIRE?

ANCHORWIRE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is Lake Region Medical. The 510(k) number is K111288.

When did ANCHORWIRE GUIDEWIRE receive FDA 510(k) clearance?

ANCHORWIRE GUIDEWIRE received FDA 510(k) clearance on 2011-08-02, under 510(k) number K111288.

Who is the listed applicant for ANCHORWIRE GUIDEWIRE?

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

What is the FDA product code for ANCHORWIRE GUIDEWIRE?

The FDA product code for ANCHORWIRE GUIDEWIRE is DQX.

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Other records listing Lake Region Medical as applicant

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Related Devices (Code: DQX)

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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.