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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter for crossing total occlusions
510(k) Number K072155
Device Name PIONEER CATHETER
Applicant
MEDTRONIC INC.
3576 UNOCAL PLACE
SANTA ROSA,  CA  95403 -1774
Applicant Contact CATHERINE PRIESTLEY
Correspondent
MEDTRONIC INC.
3576 UNOCAL PLACE
SANTA ROSA,  CA  95403 -1774
Correspondent Contact CATHERINE PRIESTLEY
Regulation Number870.1250
Classification Product Code
PDU  
Subsequent Product Code
ITX  
Date Received08/03/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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