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, Intravascular, Diagnostic
510(k) Number K060010
Device Name NAUTIFLUX
Applicant
Sedat
8895 Towne Centre Dr. 105-416
San Diego,  CA 
Applicant Contact LAETITIA COUSIN
Correspondent
Sedat
8895 Towne Centre Dr. 105-416
San Diego,  CA 
Correspondent Contact LAETITIA COUSIN
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
DXO  
Date Received01/03/2006
Decision Date 08/04/2006
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
-
-