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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-04-28 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K170616.

When did van Andel Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for van Andel Dilatation Catheter?

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 van Andel Dilatation Catheter?

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

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Related Devices (Code: DRE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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