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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 K072130
Device Name PTFE PEEL AWAY MICROINTRODUCER
Applicant
Intromed
148 S. 1200 E.
Salt Lake City,  UT  84102
Applicant Contact PHIL TRIOLO
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/02/2007
Decision Date 10/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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