S-Wire Guidewire System

Basic Information

• Brand Name: S-Wire Guidewire System
• Primary DI: 00814384020437
• Version / Model: 511980-001
• Company Name: CONCERT MEDICAL, LLC
• Labeler DUNS: 189689800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-04-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f23d4a17-3683-4eda-98a2-d940e66b531e

Device Description

The S-Wire Guidewire System is a sterile, single-use guidewire intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those in trans-catheter aortic valve implantation (TAVI) procedures.

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: Yes
• 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
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814384020437	GS1
Unit of Use	00814384020420	GS1

Premarket Submissions

Submission Number	Supplement Number
K153397	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.035	Inch
Length	260	Centimeter