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FDA 510(k) Application Details - K181126
Device Classification Name
More FDA Info for this Device
510(K) Number
K181126
Device Name
Reprocessed Visions PV .035 Digital IVUS Catheter
Applicant
Innovative Health, LLC
1435 North Hayden Road, Suite 100
Scottsdale, AZ 85257 US
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Contact
Amanda Babcock
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Regulation Number
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Classification Product Code
OWQ
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More FDA Info for this Product Code
Date Received
04/30/2018
Decision Date
01/18/2019
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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