PRECIOUS PLUS GUIDE CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K072316
Device Name PRECIOUS PLUS GUIDE CATHETER
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 870.1250
Classification Product Code
DQY  
Date Received 08/17/2007
Decision Date 09/17/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No