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FDA 510(k) Application Details - K083343
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K083343
Device Name
Catheter, Percutaneous
Applicant
MICROVENTION, INC.
75 COLUMBIA
SUITE A
ALISO VIEJO, CA 92656-1408 US
Other 510(k) Applications for this Company
Regulation Number
870.1250
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Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2008
Decision Date
12/04/2008
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
Y
Expedited Review
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