Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name injector and syringe, angiographic
510(k) Number K884913
Device Name MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
Applicant
MERIT MEDICAL SYSTEMS, INC.
79 WEST 4500 SOUTH
SUITE 9
SALT LAKE CITY,  UT  84107
Applicant Contact FRED LAMPROPOULOS
Correspondent
MERIT MEDICAL SYSTEMS, INC.
79 WEST 4500 SOUTH
SUITE 9
SALT LAKE CITY,  UT  84107
Correspondent Contact FRED LAMPROPOULOS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/28/1988
Decision Date 04/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-