Avantec Vascular Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Avantec Vascular Corp.” (first 2003, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 147 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 147 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 264 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Avantec Vascular Corp. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| MMX | Device, Percutaneous Retrieval | 1 | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
Review panels
Most recent Avantec Vascular Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251207 | Sangria Thrombectomy System | QEW | 2026-01-07 | 264 |
| K170987 | Captus Vascular Retrieval System | MMX | 2017-08-28 | 147 |
| K032436 | DURAMAX .018 BILIARY STENT SYSTEM | FGE | 2004-02-04 | 181 |
| K030638 | DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML | FGE | 2003-07-09 | 131 |
| K030062 | ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 | LIT | 2003-04-03 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Avantec Vascular Corp..
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.
Device clinical trials
An industry sponsor named Avantec Vascular Corp. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06321575: The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial) (Recruiting, started 2024-06-20)
Frequently asked questions
How many FDA 510(k) clearances are listed under Avantec Vascular Corp.?
FDA lists 5 510(k) clearances under the applicant name “Avantec Vascular Corp.” (first 2003, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Avantec Vascular Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avantec Vascular Corp. is 147 days.
Which FDA product codes appear under Avantec Vascular Corp.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 2); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 1); MMX (Device, Percutaneous Retrieval, 1).
Next steps
- See all 5 Avantec Vascular Corp. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Avantec Vascular Corp.'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.