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FDA 510(k) Application Details - K163560
Device Classification Name
More FDA Info for this Device
510(K) Number
K163560
Device Name
Reprocessed AcuNav Diagnostic Ultrasound Catheter
Applicant
Innovative Health, LLC.
1435 North Hayden Road
Suite 100
Scottsdale, AZ 85257 US
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Contact
Rafal Chudzik
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2016
Decision Date
07/12/2017
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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