Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Arbor Endovascular, LLC — Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260537Willow 24 GuidewireArbor Endovascular, LLC2026-03-19300
K260130Willow 18 GuidewireArbor Endovascular, LLC2026-02-13280
K2531680.014” Willow GuidewireArbor Endovascular, LLC2025-11-26610
K2437560.014” Willow GuidewireArbor Endovascular, LLC2025-07-172230

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda