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 system, catheter control, steerable
510(k) Number K143227
Device Name Magellan Robotic System, Magellan Robotic Catheter 10Fr
Applicant
HANSEN MEDICAL, INC.
800 E. MIDDLEFIELD ROAD
MOUNTAIN VIEW,  CA  94043
Applicant Contact TODD MILHOLLAND
Correspondent
HANSEN MEDICAL, INC.
800 E. MIDDLEFIELD ROAD
MOUNTAIN VIEW,  CA  94043
Correspondent Contact TODD MILHOLLAND
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DRA  
Date Received11/10/2014
Decision Date 07/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-