iCast Covered Stent System

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P120003510(k) K050814

by Atrium Medical Corp.

Identity

Trade Name: iCast Covered Stent System FDA PMA
Generic Name: Iliac covered stent, arterial FDA PMA

Identifiers

PMA Number: P120003 FDA PMA
510(k) Number: K050814 FDA PMA
FDA Product Code: JCT FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 878.3720 FDA PMA
Regulation Number: 878.3720 FDA PMA
Advisory Committee: General, Plastic Surgery FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The iCast Covered Stent System is an iliac covered stent, arterial, designed to improve luminal diameter in patients with symptomatic atherosclerotic disease. It is indicated for use in the native common and/or external iliac arteries for lesions up to 110 mm in length, with a reference vessel diameter ranging from 5 to 10 mm.

This device is manufactured by Atrium Medical Corp. and has received both FDA 510(k) and PMA authorizations. It is classified as a Class 2 medical device under regulation number 878.3720.

Frequently asked questions

What is the primary indication for the iCast Covered Stent System?

The iCast Covered Stent System is indicated for improving the luminal diameter in patients suffering from symptomatic atherosclerotic disease of the native common or external iliac arteries.

What vessel dimensions are compatible with this stent system?

The device is designed for use in iliac arteries with a reference vessel diameter between 5 mm and 10 mm and is suitable for treating lesions up to 110 mm in length.

Has the iCast Covered Stent System received regulatory authorization?

Yes, the iCast Covered Stent System has received both FDA 510(k) and PMA authorizations, confirming its regulatory status for the indicated clinical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K050814	Class III	Active
FDA PMA	United States	FDA_PMA	P120003	Class III	Active

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Manufacturer

Manufacturer: Atrium Medical Corp.

Sources (2)

FDA PMA P120003 37 fields · synced Sep 18, 2026
FDA 510(k) K050814 1 fields · synced May 18, 2026