• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name syringe, balloon inflation
510(k) Number K120694
Model H74904527052, H74904527011
Device Name ENCORE 26 ADVANTAGE KIT
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311
Original Contact adrienne hotchkiss
Regulation Number870.1650
Classification Product Code
MAV  
Date Received03/07/2012
Decision Date 04/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-