Contego Medical LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0131-2026Class IINeuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic ProtectSeptember 4, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251485Excipio LV Prime Thrombectomy DeviceJune 13, 2025
K230030Excipio SV Aspiration Catheter and TubingMay 30, 2023
K223897Excipio LV Thrombectomy DeviceFebruary 17, 2023
K221204Excipio SV Thrombectomy DeviceJune 23, 2022
K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionJune 9, 2022
K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionDecember 6, 2018
K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)September 6, 2018