Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011370111

FEI Number

3011370111

Entity Name

NEURAVI LIMITED

City/State/Country

Galway, IE

Establishment Address

Block 3, Ballybrit Business Park, Galway H91K5YD, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neuravi Limited (Owner Number: 10057686)

Owner / Operator Contact Address

Block 3, Ballybritt Business Park, Galway, IE-G H91K5YD, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251789

PMA Number

N/A

All Registered Proprietary Names

Catheter, Percutaneous, Neurovasculature Catheter, Percutaneous, Neurovasculature CATHETER, THROMBUS RETRIEVER CATHETER, THROMBUS RETRIEVER CATHETER, THROMBUS RETRIEVER EMBOTRAP III

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-04-19
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2021-12-21
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2020-07-15
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2018-05-14
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-08-03
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-12-10

Official Correspondent

Caroline Walsh

US Agent Details

Samuel Shimp Email: sshimp@its.jnj.com Phone: (757) 7909275

Related Public Records

Same Entity

Neuravi Limited

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

Similar Registrations

Registration Number	Establishment Name	Location
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3031311812	TORO NEUROVASCULAR, INC.	Irvine, CA, US
3016800412	ICS MEDICAL DEVICES LTD	Galway Galway (City), IE
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011370111. Last updated year: 2026. Please use registration number 3011370111 when referencing this establishment in official correspondence.