• 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 wire, guide, catheter
510(k) Number K122590
Model RA FA14181C (GA1418), RA FA14301C (GA1430)
Device Name RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
Original Applicant
TERUMO MEDICAL CORPORATION
265 davidson ave, ste 320
somerset,  NJ  08873
Original Contact stacy a kluesner, ms, rac
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/24/2012
Decision Date 03/01/2013
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
-
-