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Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180086
510(k) Type
Traditional
Applicant
Gyrus ACMI, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2018
Days to Decision
55 days
Submission Type
Summary

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180086
510(k) Type
Traditional
Applicant
Gyrus ACMI, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2018
Days to Decision
55 days
Submission Type
Summary