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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 K031417
Device Name ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
Applicant
Intra Luminal Therapeutics, Inc.
6354 Corte Del Abeto, Suite A
Carlsbad,  CA  92009
Applicant Contact PAMELA MISAJON
Correspondent
Intra Luminal Therapeutics, Inc.
6354 Corte Del Abeto, Suite A
Carlsbad,  CA  92009
Correspondent Contact PAMELA MISAJON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/05/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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