Last synced on 25 November 2022 at 11:04 pm

Elation Pulmonary Balloon Dilation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213434
510(k) Type
Traditional
Applicant
Merit Medical Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2022
Days to Decision
137 days
Submission Type
Summary

Elation Pulmonary Balloon Dilation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213434
510(k) Type
Traditional
Applicant
Merit Medical Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2022
Days to Decision
137 days
Submission Type
Summary