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FDA 510(k) Application Details - K954205
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K954205
Device Name
Catheter, Peripheral, Atherectomy
Applicant
MICROVENA CORP.
1861 BUERKLE RD.
WHITE BEAR LAKE, MN 55110-5426 US
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Contact
JODI LOCHER
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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
09/07/1995
Decision Date
08/13/1996
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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