• 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, angioplasty, peripheral, transluminal
510(k) Number K121402
Models CXX-YYY-ZZZZZOTW/CFXX-YYY-ZZZZZ OTW, CXX-YYY-ZZZZZZ OTW/CFXX-YYY-ZZZZZ OTW
Device Name CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018'" G
Original Applicant
TRIREME MEDICAL, INC.
7060 koll center parkway
suite 300
pleasanton,  CA  94566
Original Contact shiva ardakani
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received05/11/2012
Decision Date 06/08/2012
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
-
-