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 Computer, Diagnostic, Programmable
510(k) Number K090017
Device Name CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Applicant Contact Balaka Das
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Correspondent Contact Balaka Das
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/02/2009
Decision Date 10/13/2009
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
Recalls CDRH Recalls
-
-