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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 K000677
Device Name ZUMA GUIDE CATHETERS
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
minneapolis,  MN  55432 -3576
Applicant Contact fred l boucher
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
minneapolis,  MN  55432 -3576
Correspondent Contact fred l boucher
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/29/2000
Decision Date 03/29/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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