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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K090394
Device Name VALVED TEARWAY INTRODUCER
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/17/2009
Decision Date 09/01/2009
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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