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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K234064
Device Name Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
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.
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.1200
Classification Product Code
OWQ  
Subsequent Product Code
OBJ  
Date Received12/22/2023
Decision Date 09/10/2024
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
Recalls CDRH Recalls
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