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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K094019
Device Name GLIDER PTA BALLOON CATHETER
Applicant
TRIREME MEDICAL INC
7060 KNOLL CENTER PARKWAY
SUITE 300
PLEASANTON,  CA  94566
Applicant Contact DENNIS SALZMANN
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact CHRIS LAVANCHY
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received12/29/2009
Decision Date 02/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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