K243101
- 510(k) number
- K243101
- Device name
- 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. OR · US
- Product code
- OWQ — Reprocessed Intravascular Ultrasound Catheter
- Decision date
- 2025-03-10
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243101.pdf
Official FDA record: K243101
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.