Scientia Vascular, Inc.
Medical device manufacturer in West Valley City, UT.
19510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260223 | Aristotle Mini GuidewireMOF · Traditional | 08/06/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | 07/16/2026SE |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional | 04/29/2026SE |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Special | 04/01/2025SE |
| K242301 | Socrates 38 CatheterQJP · Traditional | 12/04/2024SE |
| K223913 | Socrates Aspiration SystemNRY · Traditional | 09/20/2023SE |
| K223560 | Plato 17 MicrocatheterQJP · Traditional | 08/21/2023SE |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 GuidewireMOF · Special | 08/01/2023SE |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…MOF · Special | 03/10/2023SE |
| K222437 | Aristotle Colossus GuidewireMOF · Traditional | 01/26/2023SE |
| K210601 | Plato 17 MicrocatheterDQY · Traditional | 04/28/2021SE |
| K201760 | Zoom 14 GuidewireDQX · Special | 07/29/2020SE |
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…DQX · Special | 10/30/2019SE |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…MOF · Traditional | 03/22/2019SE |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo…MOF · Special | 08/07/2018SE |
| K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…DQX · Traditional | 01/22/2018SE |
| K170406 | Plato MICROCATH 27B MicrocatheterDQO · Traditional | 04/18/2017SE |
| K143398 | Plato MICROCATH 27B MicrocatheterDQO · Traditional | 06/26/2015SE |
| K121734 | Plato Microcath 27 MicrocatheterDQO · Traditional | 07/30/2012SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1235-2025 Class II | Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and…Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a… | 01/16/2025Open, Classified |
| Z-1234-2025 Class II | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration…Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a… | 01/02/2025Open, Classified |
| Z-1249-2023 Class II | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90…Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to… | 02/01/2023Open, Classified |