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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K061843
Device Name VENTURE WIRE CONTROL CATHETER, MODEL WCC
Applicant
ST. JUDE MEDICAL
6550 WEDGWOOD RD. NORTH
SUITE 150
MAPLE GROVE,  MN  55311
Applicant Contact SHANNON SPRINGER
Correspondent
ST. JUDE MEDICAL
6550 WEDGWOOD RD. NORTH
SUITE 150
MAPLE GROVE,  MN  55311
Correspondent Contact SHANNON SPRINGER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/30/2006
Decision Date 08/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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