FDA 510(k) Application Details - K000955

Device Classification Name Stylet, Catheter

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510(K) Number K000955
Device Name Stylet, Catheter
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS, MN 55432-3576 US
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Contact MIKE JOHNSON
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Regulation Number 870.1380

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Classification Product Code DRB
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Date Received 03/24/2000
Decision Date 06/16/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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