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5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K072301
510(k) Type
Traditional
Applicant
EV3 INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/18/2008
Days to Decision
214 days
Submission Type
Summary

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K072301
510(k) Type
Traditional
Applicant
EV3 INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/18/2008
Days to Decision
214 days
Submission Type
Summary