COR-KNOT

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219813
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219813

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

Product Type

Single Device Product

Effective date

3/02/2014

GMDN

45717 Suture knot pusher, single-use

Functional description

A COR-KNOT© QUICK LOAD© FASTENER is loaded into the distal end of the COR-KNOT© Device.

Suture ends are passed through the wire snare and pulled through the titanium fastener using the curved

handle. The Device is positioned against the tissue/prosthetic while suture is tensioned. The purple lever is

squeezed, crimping the titanium fastener and suture tails are cut. Releasing the lever frees the fastener

from the Device. The tissue/prosthetic is held by the suture loop with titanium fastener.

Intended purpose

COR-KNOT QUICK LOAD is intended to be used with the COR-KNOT Device to fasten suture by placing

a titanium COR-KNOT as a means of replacing hand-tied knots during cardiac and general surgical

applications.

Variant information

Quantity/pack 6 Knots per Pouch

Quantity/pack 1 Knot per Pouch

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 06:30:54 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

27-7-2018

Pending EC decision:  Braftovi, encorafenib, Opinion date: 26-Jul-2018

Pending EC decision: Braftovi, encorafenib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

24-7-2018

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.

FDA - U.S. Food and Drug Administration

20-6-2018

Advies experiment gesloten coffeeshopketen aangeboden aan ministers

Advies experiment gesloten coffeeshopketen aangeboden aan ministers

Het rapport van de Adviescommissie Experiment gesloten coffeeshopketen is vandaag aangeboden aan minister Grapperhaus van Justitie en Veiligheid en minister Bruins van Medische Zorg en Sport. Het advies van de commissie onder leiding van voorzitter professor André Knottnerus is van belang voor de inrichting van het experiment met cannabisteelt voor recreatief gebruik in de gesloten coffeeshopketen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Encorafenib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Encorafenib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-2-2019

Zycortal (Dechra Regulatory B.V.)

Zycortal (Dechra Regulatory B.V.)

Zycortal (Active substance: desoxycortone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)914 of Wed, 06 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3782/T/02

Europe -DG Health and Food Safety

1-11-2018

Comparable Overseas Reports (COR-A) pathway - First registration decision

Comparable Overseas Reports (COR-A) pathway - First registration decision

Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway

Therapeutic Goods Administration - Australia

24-9-2018

Braftovi (Pierre Fabre MEdicament)

Braftovi (Pierre Fabre MEdicament)

Braftovi (Active substance: encorafenib) - Centralised - Authorisation - Commission Decision (2018)6216 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004580/0000

Europe -DG Health and Food Safety

15-6-2018

Comparable overseas regulators (CORs) for prescription medicines

Comparable overseas regulators (CORs) for prescription medicines

Minor clarifications to the prescription medicines COR report-based process and the list of CORs for work-sharing.

Therapeutic Goods Administration - Australia