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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 K232130
Device Name Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Applicant
Surgical Instrument Services and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Stephanie Boyle Mays
Correspondent
Surgical Instrument Services and Savings, Inc.
(Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received07/17/2023
Decision Date 12/15/2023
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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