• 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 K011806
Device Name PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Applicant
SULZER INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112 -3495
Applicant Contact MARIA E BRITTLE
Correspondent
SULZER INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112 -3495
Correspondent Contact MARIA E BRITTLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/11/2001
Decision Date 09/07/2001
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
Recalls CDRH Recalls
-
-