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 K201595
Device Name Merit Hydrophilic Guide Wire
Applicant
Merit Medical Systems, Inc.
Parkmore Business Park West
Galway,  IE h91 w274
Applicant Contact Mark Mullaney
Correspondent
Merit Medical Systems, Inc.
Parkmore Business Park West
Galway,  IE H91 W274
Correspondent Contact Michael O'Sullivan
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/12/2020
Decision Date 10/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-