Last synced on 2 December 2022 at 11:04 pm

RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990867
510(k) Type
Traditional
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
9/2/1999
Days to Decision
170 days
Submission Type
Summary

RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990867
510(k) Type
Traditional
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
9/2/1999
Days to Decision
170 days
Submission Type
Summary