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FDA 510(k) Application Details - K022238
Device Classification Name
Instruments, Surgical, Cardiovascular
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510(K) Number
K022238
Device Name
Instruments, Surgical, Cardiovascular
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS, MN 55432-3576 US
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Contact
MARY ELLEN BEST
Other 510(k) Applications for this Contact
Regulation Number
870.4500
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Classification Product Code
DWS
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More FDA Info for this Product Code
Date Received
07/11/2002
Decision Date
10/09/2002
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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