• 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 K120137
Models 392330-XXXXX, 392331-XXXXX, 392332-XXXXX, 392333-XXXXX, 901023-01, 901023-02, 901023-03, 901023-32
Device Name VICTORY GUIDEWIRE (32 MODELS)
Original Applicant
BRIVANT, LTD.
parkmore west business park
galway,  EI ei
Original Contact kenneth walsh
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/17/2012
Decision Date 02/14/2012
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
-
-