510(k) K250545 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
| Applicant | Surgical Instrument Service and Savings, Inc., Redmond OR, US |
| Decision | Substantially Equivalent, Jun 5, 2025 |
| Received | Feb 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Medline Industries, LP Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:
Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems
10439072RH;
Biosense Webster SOUNDSTAR eco Open, Classified |
OWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.