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FDA 510(k) Application Details - K991194
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K991194
Device Name
Wire, Guide, Catheter
Applicant
MICROVENA CORP.
1861 BUERKLE RD.
WHITE BEAR LAKE, MN 55110-5426 US
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Contact
ANGELA MALLERY
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
04/08/1999
Decision Date
05/05/1999
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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