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FDA 510(k) Application Details - K173820
Device Classification Name
Catheter, Ultrasound, Intravascular
More FDA Info for this Device
510(K) Number
K173820
Device Name
Catheter, Ultrasound, Intravascular
Applicant
Boston Scientific Corporation
47215 Lakeview Boulevard
Femont, CA 94538 US
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Contact
Mugdha Dongre
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
OBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2017
Decision Date
01/17/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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