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 Catheter, Percutaneous
510(k) Number K050038
Device Name RELIANT STENT GRAFT BALLOON CATHETER
Applicant
Medtronic Endovascular Innovations
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact WILLIE MITCHELL
Correspondent
Medtronic Endovascular Innovations
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact WILLIE MITCHELL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/07/2005
Decision Date 04/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-