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FDA 510(k) Application Details - K152485
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K152485
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
OSTIAL CORPORATION
1221 INNSBRUCK DRIVE
SUNNYVALE, CA 94089 US
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Contact
JAKE WOLENBERG
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Regulation Number
000.0000
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Classification Product Code
LOX
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More FDA Info for this Product Code
Date Received
08/31/2015
Decision Date
02/16/2016
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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