Last synced on 25 November 2022 at 11:04 pm

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130981
510(k) Type
Traditional
Applicant
CORDIS CORP.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/12/2014
Days to Decision
337 days
Submission Type
Statement

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130981
510(k) Type
Traditional
Applicant
CORDIS CORP.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/12/2014
Days to Decision
337 days
Submission Type
Statement