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 Stylet, Catheter
510(k) Number K010906
Device Name MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
Applicant
Medtronic Vascular
4000 Lexington Ave. N.
Shoreview,  MN  55126
Applicant Contact KAREN CLEMENT
Correspondent
Medtronic Vascular
4000 Lexington Ave. N.
Shoreview,  MN  55126
Correspondent Contact KAREN CLEMENT
Regulation Number870.1380
Classification Product Code
DRB  
Date Received03/26/2001
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-