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 Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
510(k) Number K221962
Device Name LINQ II Insertable Cardiac Monitor
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Ms-Mvs11
Mounds View,  MN  55112
Applicant Contact Dianna L. Johannson
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Ms-Mvs11
Mounds View,  MN  55112
Correspondent Contact Dianna L. Johannson
Regulation Number870.1025
Classification Product Code
MXD  
Date Received07/05/2022
Decision Date 08/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-