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FDA 510(k)

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

K-Number: K180086 · 2018-03-08

ApplicantGyrus Acmi, Inc.
Decision Date2018-03-08
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2018-03-08 under approval number K180086. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K180086.

When was Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter approved by the FDA?

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-03-08, under approval number K180086.

What company makes Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is manufactured by Gyrus Acmi, Inc..

What is the FDA product code for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?

The FDA product code for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is FGE.

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Related Devices (Code: FGE)

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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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