Clearance Summary
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) received FDA 510(k) clearance under submission number K250545, sponsored by Surgical Instrument Service and Savings, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-06-05.
- Submission: K250545
- Applicant / Sponsor: Surgical Instrument Service and Savings, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2025-06-05
Classification & Regulation
This clearance is catalogued under FDA product code OWQ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.