• 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 catheter, percutaneous
510(k) Number K102657
Model 90072, 90073, 90074, 90076, 90077
Device Name CONCENTRIC BALLOON GUIDE CATHETER
Original Applicant
CONCENTRIC MEDICAL, INC.
301 e. evelyn ave.
mountain view,  CA  94041
Original Contact kirsten valley
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/15/2010
Decision Date 11/17/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-