KONAR-MF

Organization name

LifeTech Scientific (Europe) B.V.

SRN

NL-MF-000005742

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Croatia; available across 32 countries total.

Trade name

KONAR-MF

UDI-DI code

08720214000000

Basic UDI-DI

B-08720214000000

Reference / catalog number

LE-MFO-5-3

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The KONAR-MF VSD Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Ventricular Septal Defects (VSDs) in patients. The occluder is a self-expandable, double-disc device made from a Nitinol wire mesh. The two discs are linked together by a cone-shaped waist corresponding to the size of the VSD. The waist of the four largest models are sewn with PTFE membranes securely using Nylon threads in order to increase its occlusion ability and reduce the residual shunts, while the four smallest models have no membrane in it.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P07040301CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS