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WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112543
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/29/2011
Days to Decision
119 days
Submission Type
Summary

WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112543
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/29/2011
Days to Decision
119 days
Submission Type
Summary