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FDA 510(k) Application Details - K992169
Device Classification Name
Wire, Guide, Catheter
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510(K) Number
K992169
Device Name
Wire, Guide, Catheter
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA, CA 95052-8167 US
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Contact
MARGARET ANDERSON
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Regulation Number
870.1330
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Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
06/28/1999
Decision Date
10/28/1999
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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