Mi-EXT Distal Access Catheter

Basic Information

• Brand Name: Mi-EXT Distal Access Catheter
• Primary DI: B293MIEXT43300
• Version / Model: Mi-EXT-4330
• Company Name: MIVI NEUROVASCULAR
• Labeler DUNS: 076836823
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-01
• Public Version: 7
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: e106d1a1-4f65-4e51-ad7f-86df8267b836
• Distribution End Date: 2018-12-07

Device Description

The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion of angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.

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
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B293MIEXT43300	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K163233	000

Device Sizes

Type	Value	Unit	Text
Length	147	Centimeter
Catheter Gauge	4	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry and dark