510(k) K243101 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
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., Redmond OR, US |
| Decision | Substantially Equivalent, Mar 10, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243101
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.