Last synced on 25 November 2022 at 11:04 pm

Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Ste

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172044
510(k) Type
Traditional
Applicant
Cook Ireland Ltd
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
2/27/2018
Days to Decision
236 days
Submission Type
Summary

Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Ste

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172044
510(k) Type
Traditional
Applicant
Cook Ireland Ltd
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
2/27/2018
Days to Decision
236 days
Submission Type
Summary