CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018′ G


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K121402
Device Name CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018′ G
Applicant
TRIREME MEDICAL, INC.
7060 koll center parkway
suite 300
pleasanton, 
CA 
94566

Applicant Contact shiva ardakani
Correspondent
TRIREME MEDICAL, INC.
7060 koll 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 05/10/2012
Decision Date 06/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No