ASAHI PTCA GUIDE WIRE, X-TREME


Device Classification Name

wire, guide, catheter

510(k) Number K072431
Device Name ASAHI PTCA GUIDE WIRE, X-TREME
Applicant
ASAHI INTECC CO., LTD.
2500 red hill ave, suite 210
santa ana, 
CA 
92705

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

Correspodent Contact yoshi terai
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 08/29/2007
Decision Date 09/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No