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FDA 510(k) Application Details - K201170
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K201170
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
Boston Scientific Corporation
3 Scimed Place
Maple Grove, MN 55311 US
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Contact
Jennifer Mrkvicka
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
05/01/2020
Decision Date
09/15/2020
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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