Arbor Endovascular, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Arbor Endovascular, LLC” (first 2025, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. Since 2017 the median was 30 days, against 132 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 2 | 142 |
| 2026 | 3 | 29 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arbor Endovascular, LLC took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | 5 | 5 |
Review panels
- Neurology (5)
Most recent Arbor Endovascular, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262424 | Willow 12 Guidewire | MOF | 2026-08-14 | 29 |
| K260537 | Willow 24 Guidewire | MOF | 2026-03-19 | 30 |
| K260130 | Willow 18 Guidewire | MOF | 2026-02-13 | 28 |
| K253168 | 0.014 Willow Guidewire | MOF | 2025-11-26 | 61 |
| K243756 | 0.014 Willow Guidewire | MOF | 2025-07-17 | 223 |
Recalls
openFDA lists no recalls under a recalling firm named Arbor Endovascular, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Arbor Technologies, Inc. (10 510(k)s)
- Arbor Medical Innovations, LLC (1 510(k)s)
- Arbor Research Corp. (1 510(k)s)
- Arbor Vita Corportation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arbor Endovascular, LLC?
FDA lists 5 510(k) clearances under the applicant name “Arbor Endovascular, LLC” (first 2025, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Arbor Endovascular, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arbor Endovascular, LLC is 30 days. Since 2017: 30 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arbor Endovascular, LLC?
The most frequent FDA product codes under this applicant name are MOF (Guide, Wire, Catheter, Neurovasculature, 5).
Next steps
- See all 5 Arbor Endovascular, LLC clearances with predicates and recalls
- Run predicate analysis for product code MOF, Arbor Endovascular, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.