Device Classification Name |
System, Catheter Control, Steerable
|
510(k) Number |
K052480 |
Device Name |
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH |
Applicant |
HANSEN MEDICAL, INC. |
380 NORTH BERNARDO AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
NINA PELED |
Correspondent |
HANSEN MEDICAL, INC. |
380 NORTH BERNARDO AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
NINA PELED |
Regulation Number | 870.1290
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/2005 |
Decision Date | 05/02/2007 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|