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CONTEGO MEDICAL, INC

Matched from indexed company URL: 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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851616007590Neuroguard IEP® System - The Neuroguard IEP System consists of three main components:• A self-expanding nitinol stent• A delivery catheter which includes a post-dilation balloon and activation handle• Embolic protection filter that is integrated at the distal end of the delivery system+1-800-708-7271info@contegomedical.com
00851616007606Neuroguard IEP® System - The Neuroguard IEP System consists of three main components:• A self-expanding nitinol stent• A delivery catheter which includes a post-dilation balloon and activation handle• Embolic protection filter that is integrated at the distal end of the delivery system+1-800-708-7271info@contegomedical.com
00851616007613Neuroguard IEP® System - The Neuroguard IEP System consists of three main components:• A self-expanding nitinol stent• A delivery catheter which includes a post-dilation balloon and activation handle• Embolic protection filter that is integrated at the distal end of the delivery system+1-800-708-7271info@contegomedical.com

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
1865192047357300K251485Excipio LV Prime Thrombectomy DeviceQEW2025-06-13
3122782047357300K251485Excipio 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
1865191615310769K221204Excipio SV Thrombectomy DeviceQEW2022-06-23
3122781615310769K221204Excipio 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

PMN#

GUDID#