Last synced on 2 December 2022 at 11:04 pm

RX HERCULINK ELITE BILIARY STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053454
510(k) Type
Traditional
Applicant
GUIDANT CORPORATION
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/6/2006
Days to Decision
87 days
Submission Type
Summary

RX HERCULINK ELITE BILIARY STENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053454
510(k) Type
Traditional
Applicant
GUIDANT CORPORATION
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/6/2006
Days to Decision
87 days
Submission Type
Summary