ALN Optional Vena Cava Filter - Femoral Approach

Basic Information

• Brand Name: ALN Optional Vena Cava Filter - Femoral Approach
• Primary DI: 03760017680004
• Version / Model: FF.010995
• Company Name: A.L.N.
• Labeler DUNS: 272983094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 1
• Public Version Date: 2018-11-26
• Public Version Status: New
• Public Device Record Key: c42fc3a5-454e-4257-a6ce-bdd88162b016

Device Description

The device is an Optional Vena Cava Filter - Femoral Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

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: 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
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	870.3375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44864	Vena cava filter, temporary/permanent	A vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760017680004	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163699	000