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FDA 510(k) Application Details - K222065
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K222065
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
BioTronik, Inc.
6024 Jean Road
Lake Oswego, OR 97035 US
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Contact
Jon Brumbaugh
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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
07/13/2022
Decision Date
02/16/2023
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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