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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 K040922
Device Name VENTURE WIRE CONTROL CATHETER
Applicant
VELOCIMED INC.
11400 73RD AVENUE NORTH
SUITE 134
MINEAPOLIS,  MN  55369 -5567
Applicant Contact Sew-Wah Tay
Correspondent
VELOCIMED INC.
11400 73RD AVENUE NORTH
SUITE 134
MINEAPOLIS,  MN  55369 -5567
Correspondent Contact Sew-Wah Tay
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/08/2004
Decision Date 08/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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