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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 K250314
Device Name Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
Applicant
Surgical Instrument Service and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Stephanie Boyle Mays
Correspondent
Surgical Instrument Service and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.1340
Classification Product Code
PNE  
Date Received02/04/2025
Decision Date 12/19/2025
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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