FDA 510(k)

Amplatz Support Wire Guide with Apex Curve

K-Number: K171445 · 2018-01-10

Decision Date2018-01-10

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Amplatz Support Wire Guide with Apex Curve is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K171445. 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 Amplatz Support Wire Guide with Apex Curve?

Amplatz Support Wire Guide with Apex Curve is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Cook Incorporated. The 510(k) number is K171445.

When did Amplatz Support Wire Guide with Apex Curve receive FDA 510(k) clearance?

Amplatz Support Wire Guide with Apex Curve received FDA 510(k) clearance on 2018-01-10, under 510(k) number K171445.

Who is the listed applicant for Amplatz Support Wire Guide with Apex Curve?

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 Amplatz Support Wire Guide with Apex Curve?

The FDA product code for Amplatz Support Wire Guide with Apex Curve is DQX.

Other records listing Cook Incorporated 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.