West Valley City, UT, US · 13 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | Class II | Cardiovascular | 7 | 2026-09-16 |
| NRY | Catheter, Thrombus Retriever | Class II | Cardiovascular | 2 | 2026-07-16 |
| QJP | Catheter, Percutaneous, Neurovasculature | Class II | Cardiovascular | 2 | 2024-12-04 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | 1 | 2021-04-28 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | 1 | 2020-07-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-01-16 | Class II | Ongoing | Z-1235-2025 | Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and i… | — | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the ster… |
| 2025-01-02 | Class II | Ongoing | Z-1234-2025 | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suc… | — | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the ster… |
| 2023-02-01 | Class II | Ongoing | Z-1249-2023 | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 | — | Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guide… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-16 | K254181 | Aristotle 65 Macrowire | MOF | Class II | Cardiovascular |
| 2026-08-06 | K260223 | Aristotle Mini Guidewire | MOF | Class II | Cardiovascular |
| 2026-07-16 | K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | NRY | Class II | Cardiovascular |
| 2026-04-29 | K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | MOF | Class II | Cardiovascular |
| 2025-04-01 | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | MOF | Class II | Cardiovascular |
| 2024-12-04 | K242301 | Socrates 38 Catheter | QJP | Class II | Cardiovascular |
| 2023-09-20 | K223913 | Socrates Aspiration System | NRY | Class II | Cardiovascular |
| 2023-08-21 | K223560 | Plato 17 Microcatheter | QJP | Class II | Cardiovascular |
| 2023-08-01 | K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | MOF | Class II | Cardiovascular |
| 2023-03-10 | K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | MOF | Class II | Cardiovascular |
| 2023-01-26 | K222437 | Aristotle Colossus Guidewire | MOF | Class II | Cardiovascular |
| 2021-04-28 | K210601 | Plato 17 Microcatheter | DQY | Class II | Cardiovascular |
| 2020-07-29 | K201760 | Zoom 14 Guidewire | DQX | Class II | Cardiovascular |