Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)

About This 510(k) Submission

K243101 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342), a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on March 10, 2025, 161 days after receiving the submission on September 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.