CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K122070
Device Name CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
Applicant
TRIREME MEDICAL INC
7060 knoll center parkway
suite 300
pleasanton, 
CA 
94566

Applicant Contact shiva ardakani
Correspondent
TRIREME MEDICAL INC
7060 knoll center parkway
suite 300
pleasanton, 
CA 
94566

Correspodent Contact shiva ardakani
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 07/16/2012
Decision Date 08/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No