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 Catheter, Intravascular, Diagnostic
510(k) Number K191608
Device Name Impress Angiographic Catheter
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Luke Meidell
Correspondent
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Luke Meidell
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/17/2019
Decision Date 07/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-