• 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 K060927
Device Name CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
Original Applicant
CERES MEDICAL SYSTEMS, L.L.C.
13195 seagrove st
san diego,  CA  92130
Original Contact corrine bonfiglio
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/04/2006
Decision Date 10/06/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-