Foresight ICE™ Catheter

Basic Information

• Brand Name: Foresight ICE™ Catheter
• Primary DI: 00628055603016
• Version / Model: TA-01-0001
• Company Name: Conavi Medical Inc
• Labeler DUNS: 200125243
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-11
• Public Version: 1
• Public Version Date: 2020-09-21
• Public Version Status: New
• Public Device Record Key: 10b42b18-3fd2-4f2d-8a00-265ed8b5adff

Device Description

Imaging catheter

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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42584	Intracardiac ultrasound imaging catheter, steerable, single-use	A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	01628055603015	GS1		1	In Commercial Distribution
Primary	00628055603016	GS1
Package	05628055603011	GS1		5	In Commercial Distribution
Package	10628055603013	GS1		10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162789	000