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In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201165
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
12/17/2020
Days to Decision
230 days
Submission Type
Summary

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201165
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
12/17/2020
Days to Decision
230 days
Submission Type
Summary