510(k) K234064 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
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., Redmond OR, US |
| Decision | Substantially Equivalent, Sep 10, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Medline Industries, LP Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters:
ACUSON AcuNav Ultrasound Catheter, Use on GE Systems
10135910RH; 10043342RH
ACUSON AcuNav Ultrasound Catheter, Use on Siemens Syste Open, Classified |
OWQ | None listed |
| Sep 26, 2025 | Medline Industries, LP Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart Open, Classified |
OWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.