Last synced on 9 December 2022 at 11:04 pm

OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001222
510(k) Type
Special
Applicant
GUIDANT CORP.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
5/17/2000
Days to Decision
30 days
Submission Type
Summary

OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001222
510(k) Type
Special
Applicant
GUIDANT CORP.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
5/17/2000
Days to Decision
30 days
Submission Type
Summary