GLIDER PTCA BALLOON CATHETER


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K111544
Device Name GLIDER PTCA BALLOON CATHETER
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 870.5100
Classification Product Code
LOX  
Date Received 06/03/2011
Decision Date 03/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No