FINDRWIRZ GUIDE WIRE SYSTEM


Device Classification Name

wire, guide, catheter

510(k) Number K080364
Device Name FINDRWIRZ GUIDE WIRE SYSTEM
Applicant
SENTREHEART INC.
2468 embarcadero way
palo alto, 
CA 
94303

Applicant Contact linda guthrie
Correspondent
SENTREHEART INC.
2468 embarcadero way
palo alto, 
CA 
94303

Correspodent Contact linda guthrie
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 02/11/2008
Decision Date 08/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No