Last synced on 30 November 2024 at 11:09 am

UPJ Occlusion Balloon Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183323
510(k) Type
Traditional
Applicant
COOK Incorporated
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
8/5/2019
Days to Decision
248 days
Submission Type
Summary

UPJ Occlusion Balloon Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183323
510(k) Type
Traditional
Applicant
COOK Incorporated
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
8/5/2019
Days to Decision
248 days
Submission Type
Summary