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FDA 510(k) Application Details - K170311
Device Classification Name
More FDA Info for this Device
510(K) Number
K170311
Device Name
Reprocessed Agilis NxT Steerable Introducer
Applicant
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
Scottsdale, AZ 85257 US
Other 510(k) Applications for this Company
Contact
Amy Stoklas-Oakes
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2017
Decision Date
06/02/2017
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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