• 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, intravascular, diagnostic
510(k) Number K913682
Device Name MERIT CUSTOM KIT
Original Applicant
MERIT MEDICAL SYSTEMS, INC.
79 west 4500 south
suite 9
salt lake city,  UT  84107
Original Contact dennis reigle
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/19/1991
Decision Date 11/15/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-