Company ยท US
Contego Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2025 | K251485 | Excipio LV Prime Thrombectomy Device Contego Medical, Inc. | QEW |
| May 30, 2023 | K230030 | Excipio SV Aspiration Catheter and Tubing Contego Medical, Inc. | QEW |
| Feb 17, 2023 | K223897 | Excipio LV Thrombectomy Device Contego Medical, Inc. | QEW |
| Jun 23, 2022 | K221204 | Excipio SV Thrombectomy Device Contego Medical, Inc. | QEW |
| Jun 9, 2022 | K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection Contego Medical, Inc. | LIT |
| Dec 6, 2018 | K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Contego Medical, LLC | LIT |
| Sep 6, 2018 | K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) Contego Medical, LLC | LIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | Contego Medical, Inc Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV- Open, Classified |
NIM | None listed |
| Oct 10, 2025 | Contego Medical LLC Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40 Open, Classified |
NIM | None listed |