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 K132369
Device Name MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
Applicant
HANSEN MEDICAL, INC.
800 EAST MIDDLEFIELD ROAD
MOUNTAIN VIEW,  CA  94043
Applicant Contact HASSAN LABAY
Correspondent
HANSEN MEDICAL, INC.
800 EAST MIDDLEFIELD ROAD
MOUNTAIN VIEW,  CA  94043
Correspondent Contact HASSAN LABAY
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DRA  
Date Received07/30/2013
Decision Date 09/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-