FDA 510(k) clearance · back to tracker

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

Surgical Instrument Service and Savings, Inc. cleared K250545 on 2025-06-05, decision: substantially equivalent

K-number

K250545

Sponsor

Surgical Instrument Service and Savings, Inc.

Device

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-06-05

Product code

OWQ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1200

Official FDA record

Open K250545on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.