PK Papyrus | 合法醫療器材資訊網

PKPapyruscoveredcoronarystentsystemisindicatedforthetreatmentofacuteperforationsofnativecoronaryarteriesandcoronarybypassgraftsinvessels ...

Humanitarian Device. Authorized by Federal law for use in the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. The effectiveness of this device for this use has not been demonstrated.

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of, a physician (or properly licensed practitioner).

Indications: The PK Papyrus is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. Contraindications: Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated; Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium allo...