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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 K042910
Device Name VENTURE WIRE CONTROL CATHETER, MODEL WCC
Applicant
VELOCIMED INC.
11400 73RD AVE NORTH STE 134
MINNEAPOLIS,  MN  55369
Applicant Contact JOHN CARLINE
Correspondent
VELOCIMED INC.
11400 73RD AVE NORTH STE 134
MINNEAPOLIS,  MN  55369
Correspondent Contact JOHN CARLINE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/21/2004
Decision Date 11/22/2004
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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