FDA.reportPublic FDA data

CONTEGO MEDICAL, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114710563011471056CONTEGO MEDICAL, INC1N2026-01-013801 Lake Boone Trail, Suite 100 Raleigh NC US 27607
30254659183025465918CONTEGO MEDICAL, INC1N2026-01-012334D WALSH AVE Santa Clara CA US 95051

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1865191908791527P240009Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic ProtectionNIM2024-10-11
3122782047357300K251485Excipio LV Prime Thrombectomy DeviceQEW2025-06-13
1865192047357300K251485Excipio LV Prime Thrombectomy DeviceQEW2025-06-13
1865192043288582K230030Excipio SV Aspiration Catheter and TubingQEW2023-05-30
3122782043288582K230030Excipio SV Aspiration Catheter and TubingQEW2023-05-30
1865191621626879K223897Excipio LV Thrombectomy DeviceQEW2023-02-17
3122781621626879K223897Excipio LV Thrombectomy DeviceQEW2023-02-17
1865191748313749K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionLIT2022-06-09
3122781615310769K221204Excipio SV Thrombectomy DeviceQEW2022-06-23
1865191615310769K221204Excipio SV Thrombectomy DeviceQEW2022-06-23
1865191531224429K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionLIT2018-12-06
1865191504026286K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)LIT2018-09-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEW82025-06-13
LIT42022-06-09