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Occlutech ASD Occluder Procedure Pack

Occlutech International AB · Model 37ASD16P · UDI-DI 07340175602016

OZG Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder (04260182521540) is packaged with its compatible Occlutech Pistol Pusher (OPP) (8683463400161), Instructions for Use (IFU) and Patient Implant Card.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.