Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) +1 more— 510(k) K243101
Substantially EquivalentSurgical Instrument Service and Savings, Inc.
FDA 510(k) clearance K243101 for Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) +1 more, Substantially Equivalent on 2025-03-10. Applicant: Surgical Instrument Service and Savings, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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.