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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 K040481
Device Name SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
Applicant
INTRALUMINAL THERAPEUTICS, INC.
6354 CORTE DEL ABETO
SUITE A
CARLSBAD,  CA  92009
Applicant Contact PAMELA MISAJON
Correspondent
INTRALUMINAL THERAPEUTICS, INC.
6354 CORTE DEL ABETO
SUITE A
CARLSBAD,  CA  92009
Correspondent Contact PAMELA MISAJON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/25/2004
Decision Date 03/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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