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FDA 510(k) Application Details - K021285
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K021285
Device Name
Wire, Guide, Catheter
Applicant
GUIDANT CORP.
4100 HAMLINE AVE., NORTH
ST. PAUL, MN 55112-5798 US
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Contact
KAREN S ALSOP
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
04/18/2002
Decision Date
05/02/2002
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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