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ACCLARENT AERA Eustachian Tube Dilation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230742
510(k) Type
Traditional
Applicant
Acclarent, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2023
Days to Decision
271 days
Submission Type
Summary

ACCLARENT AERA Eustachian Tube Dilation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230742
510(k) Type
Traditional
Applicant
Acclarent, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2023
Days to Decision
271 days
Submission Type
Summary