HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER


Device Classification Name

system, catheter control, steerable

510(k) Number K111004
Device Name HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
Applicant
HANSEN MEDICAL, INC.
800 east middlefield road
mountain view, 
CA 
94043

Applicant Contact kate whitin
Correspondent
HANSEN MEDICAL, INC.
800 east middlefield road
mountain view, 
CA 
94043

Correspodent Contact kate whitin
Regulation Number 870.1290
Classification Product Code
DXX  
Subsequent Product Code
DRA  
Date Received 04/11/2011
Decision Date 05/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls