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FDA 510(k) Application Details - K192399
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K192399
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
Infinity Angioplasty Balloon Company, LLC
6865 N. Reynolds Rd Suite 200
Toledo, OH 43615 US
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Contact
Tiffini Wittwer
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Regulation Number
870.1250
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Classification Product Code
LIT
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Date Received
09/03/2019
Decision Date
05/20/2020
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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