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FDA 510(k) Application Details - K053400
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K053400
Device Name
Introducer, Catheter
Applicant
ACUMEN MEDICAL, INC.
275 SANTA ANA COURT
SUNNYVALE, CA 94085 US
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Contact
Marybeth Gamber
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/06/2005
Decision Date
06/19/2006
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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