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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 K101399
Device Name COAXIAL INTRODUCER SET
Applicant
Martech Medical Products
1500 Delp Dr.
Harleysville,  PA  19438 -2900
Applicant Contact Susan Pileggi
Correspondent
Martech Medical Products
1500 Delp Dr.
Harleysville,  PA  19438 -2900
Correspondent Contact Susan Pileggi
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/18/2010
Decision Date 06/17/2010
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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