iCAST

Basic Information

• Brand Name: iCAST
• Primary DI: 00650862854541
• Version / Model: 85454
• Company Name: Atrium Medical Corporation
• Labeler DUNS: 051798999
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 7
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 379879dc-a58d-432a-8ba5-849e7764c7c6
• Distribution End Date: 2024-02-29

Device Description

iCAST COVERED STENT, 7MMX16MMX120CM

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: No
• 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
JCT	Prosthesis, tracheal, expandable	General, Plastic Surgery	878.3720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43630	Polymer-metal tracheal/bronchial stent	A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00650862854541	GS1

Premarket Submissions

Submission Number	Supplement Number
K050814	000