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FDA 510(k) Application Details - K212027
Device Classification Name
Catheter, Peripheral, Atherectomy
More FDA Info for this Device
510(K) Number
K212027
Device Name
Catheter, Peripheral, Atherectomy
Applicant
Medtronic, Inc
4600 Nathan Lane North
Plymouth, MN 55442 US
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Contact
Jenny Andersen
Other 510(k) Applications for this Contact
Regulation Number
870.4875
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Classification Product Code
MCW
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More FDA Info for this Product Code
Date Received
06/29/2021
Decision Date
08/24/2021
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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