- Physicians Office Resource

Simon Nitinol Filter™ , Vena Cava Filter, Anticubital Introducer Set
Simon Nitinol Filter™ - 3320A

Device Description

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.

Environmental Conditions

No Data Available

Device Sizes

Dilator, Length, 103 Centimeter

Introducer Catheter, 7 French

Dilator, Length, 103 Centimeter
Introducer Catheter, 7 French

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DTK

Device Name: Filter, Intravascular, Cardiovascular

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3375

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00801741109218

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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