Amplatz Support Wire Guide with Apex Curve
K-Number: K171445 · 2018-01-10
ApplicantCook Incorporated
Decision Date2018-01-10
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Amplatz Support Wire Guide with Apex Curve is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-01-10 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K171445.
When was Amplatz Support Wire Guide with Apex Curve approved by the FDA?
Amplatz Support Wire Guide with Apex Curve received FDA 510(k) clearance on 2018-01-10, under approval number K171445.
What company makes Amplatz Support Wire Guide with Apex Curve?
Amplatz Support Wire Guide with Apex Curve is manufactured by Cook Incorporated.
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.
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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.