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 K043243
Device Name PRIMUS STENT AND DELIVERY SYSTEM
Applicant
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442
Applicant Contact GLEN D SMYTHE
Correspondent
EV3 INC
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442
Correspondent Contact GLEN D SMYTHE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/23/2004
Decision Date 12/09/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-