Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K990867
Device Name RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95052 -8167
Applicant Contact SANDRA SUNDELL
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95052 -8167
Correspondent Contact SANDRA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/16/1999
Decision Date 09/02/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-