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 K052965
Device Name EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
Applicant
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL,  MN  55112 -5798
Applicant Contact Linda Kleinsasser
Correspondent
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL,  MN  55112 -5798
Correspondent Contact Linda Kleinsasser
Regulation Number870.1380
Classification Product Code
DRB  
Date Received10/21/2005
Decision Date 02/13/2006
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
-
-