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FDA 510(k) Application Details - K003889
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K003889
Device Name
Introducer, Catheter
Applicant
GUIDANT CARDIAC AND VASCULAR SURGERY
1525 O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact
JACQUELINE J JACKSON
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
12/18/2000
Decision Date
01/24/2002
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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