Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
K-Number: K180086 · 2018-03-08
Device Summary
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. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K180086.
When did Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter receive FDA 510(k) clearance?
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180086.
Who is the listed applicant for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?
The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Gyrus Acmi, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FGE)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.