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FDA 510(k) Application Details - K023351
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K023351
Device Name
Catheter, Continuous Flush
Applicant
ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC
100 MAIN ST.
SUITE 120
CONCORD, MA 01742 US
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Contact
TRACY PALMER BERNS
Other 510(k) Applications for this Contact
Regulation Number
870.1210
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Classification Product Code
KRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2002
Decision Date
02/20/2003
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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