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 Electrode, Pacemaker, Temporary
510(k) Number K042190
Device Name MODEL 6416 TEMPORARY PACING LEAD SYSTEM
Applicant
Medtronic Vascular
7000 Central Ave. NE
Mail Stop T-202
Minneapolis,  MN  55432 -3576
Applicant Contact PAULA CORDERO
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Mail Stop T-202
Minneapolis,  MN  55432 -3576
Correspondent Contact PAULA CORDERO
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/12/2004
Decision Date 09/07/2004
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
Recalls CDRH Recalls
-
-