Last synced on 2 December 2022 at 11:04 pm

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163169
510(k) Type
Traditional
Applicant
COOK IRELAND LTD
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/7/2017
Days to Decision
85 days
Submission Type
Summary

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163169
510(k) Type
Traditional
Applicant
COOK IRELAND LTD
Country
Ireland
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/7/2017
Days to Decision
85 days
Submission Type
Summary