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WallFlex™ Biliary RX Stent System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223469
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
6/15/2023
Days to Decision
210 days
Submission Type
Summary

WallFlex™ Biliary RX Stent System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223469
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
6/15/2023
Days to Decision
210 days
Submission Type
Summary