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 K990592
Device Name INTRASTENT II
Applicant
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112
Applicant Contact CATHY YOHNK
Correspondent
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112
Correspondent Contact CATHY YOHNK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/24/1999
Decision Date 09/01/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-