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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wire, Guide, Catheter
510(k) Number K884274
Device Name BUCHBINDER MULTIFLEX GUIDEWIRE
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact ALAN MARQUARDT
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact ALAN MARQUARDT
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/12/1988
Decision Date 12/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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