Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
FDA 510(k) clearance K234064 · decided 2024-09-10
Clearance details
- K-number
- K234064
- Device name
- Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-22
- Decision date
- 2024-09-10
- Days to decision
- 263 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasoun recall (Z-1325-2026) | Medline Industries, LP | 2026-02-06 |
| Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualiza recall (Z-2614-2025) | Medline Industries, LP | 2025-09-26 |