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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 K033540
Device Name TRANSXCHANGE SUPPORT CATHETER
Applicant
Medtronic Vascular
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact LEISA MARTINEZ
Correspondent
Medtronic Vascular
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact LEISA MARTINEZ
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/10/2003
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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