ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE


Device Classification Name

guide, wire, catheter, neurovasculature

510(k) Number K110584
Device Name ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
Applicant
ASAHI INTECC CO., LTD.
2500 red hill suite 210
santa ana, 
CA 
92705

Applicant Contact yoshi terai
Correspondent
ASAHI INTECC CO., LTD.
2500 red hill suite 210
santa ana, 
CA 
92705

Correspodent Contact yoshi terai
Regulation Number 870.1330
Classification Product Code
MOF  
Date Received 03/01/2011
Decision Date 08/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No