Artisan Extend®

Basic Information

• Brand Name: Artisan Extend®
• Primary DI: 00815671020109
• Version / Model: 12412
• Catalog Number: 12412
• Company Name: HANSEN MEDICAL, INC.
• Labeler DUNS: 128941304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 39288c14-82bb-42d9-89e5-37a122a97a20

Device Description

Artisan Extend Control 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: No
• Has Lot/Batch Number: Yes
• 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
DRA	Catheter, Steerable	Cardiovascular	870.1280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17613	Cardiac ventriculography catheter	A flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introduced into a peripheral blood vessel and its distal tip is placed in the left or right ventricle according to the desired ventriculography. Left ventriculography is used to assess impairment of the left ventricle, the presence of ventricular aneurysms or septal defects, or to assess the mitral valve. Right ventriculography is used mostly to asses congenital heart disease. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815671020109	GS1

Customer Contacts

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