Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K091808 |
Device Name |
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 |
Applicant |
HANSEN MEDICAL, INC. |
800 E. MIDDLEFIELD ROAD |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
KATE WHITIN |
Correspondent |
HANSEN MEDICAL, INC. |
800 E. MIDDLEFIELD ROAD |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
KATE WHITIN |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 06/18/2009 |
Decision Date | 09/10/2009 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|