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FDA 510(k) Application Details - K965183
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K965183
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA, CA 95052-8167 US
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MONA MIRAPURI
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
LIT
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More FDA Info for this Product Code
Date Received
12/24/1996
Decision Date
04/24/1997
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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