FDA 510(k) Application Details - K043179

Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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510(K) Number K043179
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55038 US
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Contact RONALD W BENNETT
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Regulation Number 870.4210

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Classification Product Code DWF
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Date Received 11/17/2004
Decision Date 02/08/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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