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 Wire, Guide, Catheter
510(k) Number K261640
Device Name Merit MAK Nitinol/Gold-Tungsten Guide Wire
Applicant
Merit Medical Ireland , Ltd.
Parkmore Business Park W.
Galway,  IE
Applicant Contact Siobhan King
Correspondent
Merit Medical Ireland , Ltd.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact Siobhan King
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/18/2026
Decision Date 07/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-