COR-KNOT

Main information

  • Trade name:
  • COR-KNOT Device - Suture knot pusher, single-use
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • COR-KNOT Device - Suture knot pusher, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219812
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219812

Device Technologies Australia Pty Ltd - COR-KNOT Device - Suture knot pusher, single-use

ARTG entry for

Medical Device Included Class III

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

3/02/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

LSI Solutions

7796 Victor Mendon Road

VICTOR, NY, 14564

United States Of America

Products

1. COR-KNOT Device - Suture knot pusher, single-use

Product Type

Single Device Product

Effective date

3/11/2016

GMDN

45717 Suture knot pusher, single-use

Functional description

The COR-KNOT Devices are loaded at the distal end with a COR-KNOT FASTENER and appropriately

positioned at a suture closure site, squeezing the purple lever which instantly crimps the titanium fastener

and secures and trims the suture.

Intended purpose

The COR-KNOT Devices are used in conjunction with a specified suture and a COR-KNOT titanium

fastener are indicted for use to fasten and trim suture in general and cardiovascular surgical applications.

Variant information

Product name (see guidance docs) Cor-Knot Device

(030925)

Product name (see guidance docs) Cor-Knot Mini

Device ± Device Kit (031400)

Diameter (mm) 5 (Cor-Knot)

Diameter (mm) 4 (Mini)

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 06:31:10 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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