CGuard Prime Carotid Stent System

Basic Information

• Brand Name: CGuard Prime Carotid Stent System
• Primary DI: 07290120281776
• Version / Model: CND1030
• Catalog Number: CND1030
• Company Name: INSPIRE M.D LTD
• Labeler DUNS: 514477996
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-02
• Public Version: 1
• Public Version Date: 2025-07-10
• Public Version Status: New
• Public Device Record Key: 418ba079-f856-4d13-9578-526e05fabd01

Device Description

CGuard Prime Carotid Stent System 135cm,10mmx30mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIM	Stent, Carotid	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61563	Mesh-sleeve carotid artery stent	A non-bioabsorbable tubular device wrapped in a flexible fine mesh dedicated to implantation in a carotid artery to improve its luminal diameter in patients with atherosclerotic carotid artery disease. It consists of a metal framework with a polymeric mesh sleeve, typically intended to prevent restenosis. The stent is intended to be inserted and expanded using a balloon catheter. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07290120281974	GS1		1	In Commercial Distribution
Primary	07290120281776	GS1

Premarket Submissions

Submission Number	Supplement Number
P240029	000