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Elation Wireguided Balloon Dilation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151925
510(k) Type
Traditional
Applicant
MERIT MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/6/2015
Days to Decision
116 days
Submission Type
Summary

Elation Wireguided Balloon Dilation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151925
510(k) Type
Traditional
Applicant
MERIT MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/6/2015
Days to Decision
116 days
Submission Type
Summary