K243101

Substantially Equivalent

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)

Applicant: Surgical Instrument Service and Savings, Inc.
Product code: OWQ
Advisory panel: Cardiovascular
Date received: 2024-09-30
Decision date: 2025-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, OR, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.