GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE


Device Classification Name

catheter, percutaneous

510(k) Number K103534
Device Name GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
Applicant
TRIREME MEDICAL, INC.
7060 koll center parkway
suite 300
pleasanton, 
CA 
94566

Applicant Contact shiva ardakani
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 12/01/2010
Decision Date 01/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No