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FDA 510(k) Application Details - K150262
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K150262
Device Name
Filter, Intravascular, Cardiovascular
Applicant
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego, CA 92130 US
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Contact
Elaine Alan
Other 510(k) Applications for this Contact
Regulation Number
870.3375
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Classification Product Code
DTK
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More FDA Info for this Product Code
Date Received
02/04/2015
Decision Date
04/03/2015
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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