Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Scientia Vascular with 20 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Sep 16, 2026: Aristotle 65 Macrowire.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 16, 2026 | Aristotle 65 MacrowireK254181 · MOF | 510(k) clearances |
| Aug 6, 2026 | Aristotle Mini GuidewireK260223 · MOF | 510(k) clearances |
| Jul 16, 2026 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)K260002 · NRY | 510(k) clearances |
| Apr 29, 2026 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireK253579 · MOF | 510(k) clearances |
| Apr 1, 2025 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireK243938 · MOF | 510(k) clearances |
| Jan 16, 2025 | Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostiClass II · Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this cou | Device recalls |
| Jan 2, 2025 | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intendeClass II · Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this cou | Device recalls |
| Dec 4, 2024 | Socrates 38 CatheterK242301 · QJP | 510(k) clearances |
| Sep 20, 2023 | Socrates Aspiration SystemK223913 · NRY | 510(k) clearances |
| Aug 21, 2023 | Plato 17 MicrocatheterK223560 · QJP | 510(k) clearances |
| Feb 1, 2023 | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090Class II · Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
