• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, biliary, diagnostic
510(k) Number K112701
Device Name CHARGER BALLOON DILATATION CATHETER
Original Applicant
BOSTON SCIENTIFIC
one scimed place
maple grove,  MN  55311 -1566
Original Contact glenn jacques
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/16/2011
Decision Date 10/25/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-