510(k) K232130 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
| Applicant | Surgical Instrument Services and Savings, Inc., Redmond OR, US |
| Decision | Substantially Equivalent, Dec 15, 2023 |
| Received | Jul 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232130
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Medline Industries, LP Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:
ViewFlex Xtra ICE Catheter 9F x 90cm
D087031RH
20197344019554 Open, Classified |
OWQ | None listed |
| Sep 26, 2025 | Medline Industries, LP Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH Open, Classified |
OWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.