Contego Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Contego Medical, Inc.” (first 2022, latest 2025), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 51 days. Since 2017 the median was 51 days, against 78 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 |
|---|---|---|
| 2022 | 2 | 44 |
| 2023 | 2 | 98 |
| 2024 | 0 | — |
| 2025 | 1 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Contego Medical, Inc. took a median 51 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 78 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 4 | 4 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| NIM | Stent, Carotid | 1 | 0 |
Review panels
- Cardiovascular (6)
Most recent Contego Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251485 | Excipio LV Prime Thrombectomy Device | QEW | 2025-06-13 | 30 |
| K230030 | Excipio SV Aspiration Catheter and Tubing | QEW | 2023-05-30 | 145 |
| K223897 | Excipio LV Thrombectomy Device | QEW | 2023-02-17 | 51 |
| K221204 | Excipio SV Thrombectomy Device | QEW | 2022-06-23 | 58 |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | LIT | 2022-06-09 | 31 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240009 | PMA | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | 2024-10-11 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-06-29.
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 Contego Medical, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05845710: Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III) (Completed, started 2023-10-05)
- NCT04201132: Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System (Active not recruiting, started 2020-06-12)
- NCT04142541: Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis (Completed, started 2018-02-28)
- NCT03271710: Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System (Completed, started 2017-09-01)
- NCT02501148: A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection (Completed, started 2015-08)
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.
- Contego Medical, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Contego Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Contego Medical, Inc.” (first 2022, latest 2025), plus 1 PMA decision, across 3 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 Contego Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contego Medical, Inc. is 51 days. Since 2017: 51 days, versus 78 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Contego Medical, Inc.?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 4); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 1); NIM (Stent, Carotid, 1).
Next steps
- See all 5 Contego Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEW, Contego Medical, Inc.'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.