Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011471056

FEI Number

3011471056

Entity Name

CONTEGO MEDICAL, INC

City/State/Country

Raleigh, NC, US

Establishment Address

3801 Lake Boone Trail, Suite 100, Raleigh, NC 27607, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Contego Medical, INC (Owner Number: 10050012)

Owner / Operator Contact Address

3801 Lake Boone Trail, Suite 100, Raleigh, NC 27607, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221204

PMA Number

N/A

All Registered Proprietary Names

Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection Excipio LV Thrombectomy Device Excipio SV Thrombectomy Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIM	Stent, Carotid	Unknown	Class 3	N/A	2024-10-16
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2023-08-15
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-12-12

Official Correspondent

James Clossick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Contego Medical, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025465918	CONTEGO MEDICAL, INC	Santa Clara, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241362	Surmodics,Inc.	Pounce XL Thrombectomy System (PTS-1011-7F135)	2024-09-11
K220887	Inari Medical	Mini-ClotTriever Thrombectomy System	2022-08-04
K250421	Inari Medical, Inc.	InThrill Thrombectomy System	2025-05-12
K192036	Inari Medical	ClotTriever Thrombectomy System	2019-08-29

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2939561	ABBOTT VASCULAR	SANTA CLARA, CA, US
2011171	Sterigenics US LLC	Los Angeles, CA, US
2124215	Boston Scientific Corporation	Saint Paul, MN, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011471056. Last updated year: 2026. Please use registration number 3011471056 when referencing this establishment in official correspondence.