OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI

Occlutech Tibbi Ürünler manufactures cardiac defect occluders, specifically the Occlutech Pistol Pusher. These devices are designed for transcatheter placement to close heart defects like atrial septal defects or patent foramen ovale. The focus is on treating structural cardiac conditions with implantable solutions.

The company is based in the United States. This location aligns with its regulatory obligations, including compliance with U.S. device classification and authorisation processes.

Occlutech’s devices, such as the Occlutech Pistol Pusher, are listed in the FDA’s Unique Device Identifier (UDI) database. This inclusion confirms their regulatory status and identification in the U.S. market.

Occlutech’s cardiac defect occluders fall under Class III device classification in the United States. This classification requires premarket approval (PMA) due to the devices’ high-risk nature, as they are intended for life-sustaining or life-supporting use or pose a potential unreasonable risk of illness or injury.