GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS

Device Classification Name

catheter, embolectomy

510(k) Number K040010
Device Name GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS
Applicant
GENESIS MEDICAL INTERVENTIONAL, INC.
652 bair island road
suite 103
redwood city, 
CA 
94063

Applicant Contact anne worden
Correspondent
GENESIS MEDICAL INTERVENTIONAL, INC.
652 bair island road
suite 103
redwood city, 
CA 
94063

Correspodent Contact anne worden
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 01/05/2004
Decision Date 07/19/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No