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In-Ka Ureteral Balloon Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201007
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
6/11/2020
Days to Decision
55 days
Submission Type
Summary

In-Ka Ureteral Balloon Dilatation Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201007
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
6/11/2020
Days to Decision
55 days
Submission Type
Summary