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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Catheter Introducer
510(k) Number K170311
Device Name Reprocessed Agilis NxT Steerable Introducer
Applicant
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Applicant Contact Amy Stoklas-Oakes
Correspondent
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Correspondent Contact Amy Stoklas-Oakes
Regulation Number870.1340
Classification Product Code
PNE  
Date Received02/01/2017
Decision Date 06/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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