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)— 510(k) K243101

Substantially Equivalent

Surgical Instrument Service and Savings, Inc.

FDA 510(k) clearance K243101 for 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), Substantially Equivalent on 2025-03-10. Applicant: Surgical Instrument Service and Savings, Inc..

Clearance details

Applicant
Surgical Instrument Service and Savings, Inc.
Product code
Code OWQ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redmond, OR, US
Download summary PDFView on FDA.gov ↗

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