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 introducer, catheter
510(k) Number K854559
Device Name MEDTRONIC PERMANENT LEAD INTRODUCER
Applicant
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS,  MN  55440 -9087
Applicant Contact ALAN MARQUARDT
Correspondent
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS,  MN  55440 -9087
Correspondent Contact ALAN MARQUARDT
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/14/1985
Decision Date 12/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-