FDA applicant
Scientia Vascular, LLC
FDA records 20 decisions for Scientia Vascular, LLC (West Valley City, UT) from 2012 to 2026: 20 510(k) clearances. Most are in product codes MOF (Guide, Wire, Catheter, Neurovasculature) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 176 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 23 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Scientia Vascular, Inc.”, “Scientia Vascular”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Scientia Vascular, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Scientia Vascular, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Scientia”
FDA records each applicant name separately; these may or may not be the same firm.