Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031658894

FEI Number

3031658894

Entity Name

INSPIREMD, LTD.

City/State/Country

Tel Aviv, IL

Establishment Address

4 Menorat HaMaor Street, Tel Aviv 6744832, IL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

InspireMD, Ltd. (Owner Number: 10093698)

Owner / Operator Contact Address

4 Menorat HaMaor Street, Tel Aviv, IL-NOTA 6744832, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P240029

All Registered Proprietary Names

CGuard Prime Carotid Stent System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIM	Stent, Carotid	Unknown	Class 3	N/A	2025-06-25

Official Correspondent

Sonali Dewan

US Agent Details

Sonali Dewan Email: Sonalid@inspiremd.com Phone: (786) 4253292

Related Public Records

Same Entity

InspireMD, Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031658894. Last updated year: 2026. Please use registration number 3031658894 when referencing this establishment in official correspondence.