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 Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K062251
FOIA Releasable 510(k) K062251
Device Name REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Applicant Contact GLENN JACQUES
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Correspondent Contact GLENN JACQUES
Regulation Number870.1220
Classification Product Code
DRF  
Date Received08/03/2006
Decision Date 10/20/2006
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
-
-