Agilis™ NxT Steerable Introducer Dual-Reach™

Basic Information

• Brand Name: Agilis™ NxT Steerable Introducer Dual-Reach™
• Primary DI: 05415067051851
• Version / Model: SI-1371-M
• Catalog Number: SI-1371-M
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-07
• Public Version: 1
• Public Version Date: 2025-02-17
• Public Version Status: New
• Public Device Record Key: cd9dfd99-d8ce-4dd3-83c1-60168a1b4f2a

Device Description

Steerable Introducer

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DYB	Introducer, catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067051851	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243493	000

Device Sizes

Type	Value	Unit	Text
Length	71.0000	Centimeter
Catheter Gauge	13.0000	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Excursions permitted from -20°C to 50°C, and 10%-90% store at room temperature 10°C to 25°C, Keep dry, keep away from sunlight, protect from heat and radioactive sources