FDA 510(k)

APPROACH PRO ST WIRE GUIDE

K-Number: K110163 · 2011-02-25

Decision Date2011-02-25

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

APPROACH PRO ST WIRE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2011-02-25 under 510(k) number K110163. 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 APPROACH PRO ST WIRE GUIDE?

APPROACH PRO ST WIRE GUIDE is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Cook Incorporated. The 510(k) number is K110163.

When did APPROACH PRO ST WIRE GUIDE receive FDA 510(k) clearance?

APPROACH PRO ST WIRE GUIDE received FDA 510(k) clearance on 2011-02-25, under 510(k) number K110163.

Who is the listed applicant for APPROACH PRO ST WIRE GUIDE?

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

What is the FDA product code for APPROACH PRO ST WIRE GUIDE?

The FDA product code for APPROACH PRO ST WIRE GUIDE is 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.