Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K141822 |
Device Name |
SENSEI X ROBOTIC CATHETER SYSTEM |
Applicant |
HANSON MEDICAL, INC. |
800 EAST MIDDLEFIELD RD |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
TODD MILHOLLAND |
Correspondent |
HANSON MEDICAL, INC. |
800 EAST MIDDLEFIELD RD |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
TODD MILHOLLAND |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 07/07/2014 |
Decision Date | 08/05/2014 |
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
|
|
|