S-Wire Guidewire System

GUDID 00814384020437

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.

CONCERT MEDICAL, LLC

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00814384020437
• NIH Device Record Key: f23d4a17-3683-4eda-98a2-d940e66b531e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-Wire Guidewire System
• Version Model Number: 511980-001
• Company DUNS: 189689800
• Company Name: CONCERT MEDICAL, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 260 Centimeter
• Length: 260 Centimeter
• Length: 260 Centimeter
• Length: 260 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814384020420 [Unit of Use]
GS1	00814384020437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153397

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-25

Devices Manufactured by CONCERT MEDICAL, LLC

• 00814384020437 - S-Wire Guidewire System: 2018-07-06The 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.
• 00814384020437 - S-Wire Guidewire System: 2018-07-06 The S-Wire Guidewire System is a sterile, single-use guidewire intended to facilitate the introduction and placement of interven
• 00814384020017 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020031 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020055 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020079 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020093 - Galeo EW: 2018-03-29 Extension Guidewire
• 00814384020116 - Galeo HYDRO: 2018-03-29 Coronary Guidewire
• 00814384020130 - Galeo HYDRO: 2018-03-29 Coronary Guidewire