SeQureTM Snare System

Basic Information

• Brand Name: SeQureTM Snare System
• Primary DI: 06938370118121
• Version / Model: LT-SM-07
• Company Name: Lifetech Scientific (Shenzhen) Co., Ltd.
• Labeler DUNS: 529864170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-17
• Public Version: 4
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: c237f96f-682e-442a-b491-7f932178e450

Device Description

The SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformiation because of super-elasticity of nitinol material. The catheter consists of luer connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
MMX	Device, Percutaneous Retrieval	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17927	Intravascular extraction catheter-snare	A flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06938370118121	GS1

Premarket Submissions

Submission Number	Supplement Number
K102484	000