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FDA 510(k)

van Andel Dilatation Catheter

K-Number: K170616 · 2017-04-28

ApplicantCook Incorporated
Decision Date2017-04-28
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

van Andel Dilatation Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-04-28 under approval number K170616. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the van Andel Dilatation Catheter?

van Andel Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Cook Incorporated. The 510(k) number is K170616.

When was van Andel Dilatation Catheter approved by the FDA?

van Andel Dilatation Catheter received FDA 510(k) clearance on 2017-04-28, under approval number K170616.

What company makes van Andel Dilatation Catheter?

van Andel Dilatation Catheter is manufactured by Cook Incorporated.

What is the FDA product code for van Andel Dilatation Catheter?

The FDA product code for van Andel Dilatation Catheter is DRE.

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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.

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