• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name device, percutaneous retrieval
510(k) Number K122088
Device Name MERIT ONE SNARE SYSTEM
Original Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan,  UT  84095
Original Contact mark mullaney
Regulation Number870.5150
Classification Product Code
MMX  
Date Received07/16/2012
Decision Date 12/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-