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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 K043084
Device Name PREMERE DELIVERY SHEATH, MODEL PDS
Applicant
VELOCIMED INC.
6550 WEDGWOOD RD. NORTH
SUITE 150
MINNEAPOLIS,  MN  55311
Applicant Contact JOHN CARLINE
Correspondent
VELOCIMED INC.
6550 WEDGWOOD RD. NORTH
SUITE 150
MINNEAPOLIS,  MN  55311
Correspondent Contact JOHN CARLINE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/08/2004
Decision Date 05/02/2005
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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