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)
FDA 510(k) clearance K243101 · decided 2025-03-10
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-30
- Decision date
- 2025-03-10
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- OWQ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.