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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 K132617
Device Name MEDTRONIC INPUT PS INTRODUCER
Applicant
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact NISARG SHAH
Correspondent
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact NISARG SHAH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/21/2013
Decision Date 04/30/2014
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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