FDA 510(k)

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

K-번호: K180086 · 2018-03-08

결정일2018-03-08

제품 코드FGE

자문 위원회GU

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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.

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