Vascutek, Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Vascutek, Ltd.” (first 1991, latest 2025), plus 1 PMA decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Since 2017 the median was 240 days, against 107 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.
Caduvo groups this applicant name under Terumo, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 276 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 90 |
| 2021 | 1 | 202 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 210 |
| 2025 | 1 | 272 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vascutek, Ltd. took a median 240 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 22 | 22 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| QSK | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment | 1 | 0 |
Review panels
- Cardiovascular (27)
Most recent Vascutek, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241550 | Gelweave Vascular Prostheses | DSY | 2025-02-27 | 272 |
| K241070 | Gelsoft Plus Vascular Prostheses | DSY | 2024-11-15 | 210 |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | DSY | 2021-04-06 | 202 |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | DXZ | 2020-07-08 | 90 |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | DSY | 2017-07-14 | 282 |
| K162794 | Gelweave Vascular Grafts | DSY | 2017-06-30 | 269 |
| K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | DSY | 2010-01-07 | 27 |
| K092863 | MAXIFLO, TAPERFLO | DSY | 2009-10-08 | 21 |
| K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS | DSY | 2009-08-31 | 75 |
| K090987 | VASCUTEK BRANCHED GELWEAVE | DSY | 2009-06-19 | 73 |
16 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210006 | PMA | Thoraflex Hybrid | 2022-04-19 |
Recalls
6 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2025-12-18.
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 Vascutek, Ltd. is the lead sponsor of 7 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07078383: A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta (Recruiting, started 2025-12-19)
- NCT05639400: Thoraflex Hybrid and Relay Extension Post-Approval Study (Active not recruiting, started 2023-03-17)
- NCT04545502: PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches (Recruiting, started 2021-02-17)
- NCT04246463: Terumo Aortic Global Endovascular Registry (Recruiting, started 2019-12-17)
- NCT03180996: Global Fenestrated Anaconda Clinical STudy (Active not recruiting, started 2017-09-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vascutek, Ltd.?
FDA lists 26 510(k) clearances under the applicant name “Vascutek, Ltd.” (first 1991, latest 2025), plus 1 PMA decision, across 5 product codes 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 Vascutek, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vascutek, Ltd. is 72 days. Since 2017: 240 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vascutek, Ltd.?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 22); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 26 Vascutek, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Vascutek, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.