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


Device Classification Name

catheter, percutaneous

510(k) Number K111738
Device Name CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Applicant
TRIREME MEDICAL, INC.
7060 koll center parkway
suite 300
pleasanton, 
CA 
94566

Applicant Contact shiva ardakami
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 06/21/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No