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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 K250305
Device Name Reprocessed Agilis NxT Steerable Introducer
Applicant
Innovative Health
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Applicant Contact Rick Ferreira
Correspondent
Innovative Health
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Correspondent Contact Meerna Muradvich
Regulation Number870.1340
Classification Product Code
PNE  
Date Received02/03/2025
Decision Date 01/07/2026
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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