Soft-Vu

Basic Information

• Brand Name: Soft-Vu
• Primary DI: H787107096040
• Version / Model: 10709604
• Company Name: ANGIODYNAMICS, INC.
• Labeler DUNS: 079105071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 5
• Public Version Date: 2023-11-07
• Public Version Status: Update
• Public Device Record Key: 00332b27-48de-49ad-8e65-9951e7b20b6d
• Distribution End Date: 2023-11-06

Device Description

Soft-Vu Angiographic Catheter, Halo, Non-Braided

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
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H787107096045	HIBCC	BOX	10	Not in Commercial Distribution	2023-11-06
Primary	H787107096040	HIBCC
Secondary	15051684007184	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112452	000
K161596	000
K173762	000

Device Sizes

Type	Value	Unit	Text
Pressure	1050	Pound per Square Inch
Catheter Gauge	5	French
Outer Diameter	1.8	Millimeter
Length	90	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 27 Degrees Celsius