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FDA 510(k) Application Details - K100840
Device Classification Name
Catheter, Embolectomy
More FDA Info for this Device
510(K) Number
K100840
Device Name
Catheter, Embolectomy
Applicant
HOTSPUR TECHNOLOGIES
880 MAUDE AVENUE
SUITE A
MOUNTAIN VIEW, CA 94043 US
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Contact
Eric Ankerud
Other 510(k) Applications for this Contact
Regulation Number
870.5150
More FDA Info for this Regulation Number
Classification Product Code
DXE
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More FDA Info for this Product Code
Date Received
03/24/2010
Decision Date
07/12/2010
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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