Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K151730 |
Device Name |
Magellan Robotic System |
Applicant |
HANSEN MEDICAL, INC. |
800 EAST MIDDLEFIELD ROAD |
MOUNTAIN VIEW,
CA
94034
|
|
Applicant Contact |
TODD MILHOLLAND |
Correspondent |
HANSEN MEDICAL, INC. |
800 EAST MIDDLEFIELD ROAD |
MOUNTAIN VIEW,
CA
94034
|
|
Correspondent Contact |
TODD MILHOLLAND |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 06/26/2015 |
Decision Date | 07/23/2015 |
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
|
|
|