Boston Scientific AngioJet Ultra Thrombectomy System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.

Class:

Class D medical device

Manufactured by:

Boston Scientific Corporation

Therapeutic area:

Cardiovascular

Therapeutic indications:

The AngioJet Ultra 5000A Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra System malfunction warnings. The Console is intended for use only in conjunction with an AngioJet Ultra Thrombectomy Set. The AngioJet Ultra Thrombectomy Set are intended for thrombectomy from/in: - A-V access conduits - the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement. - upper and lower extremity peripheral arteries - upper extremity peripheral veins - ileofemoral and lower extremity veins - Main pulmonary and lobar arteries ≥ 6 mm in diameter

Product summary:

Device System Info:[Sterile Medical Device], ETO; Models: AngioJet™ Ultra System Console - 5000 A, AngioJet™ AVX™ Thrombectomy Set - 105039-003, AngioJet™ Spiroflex™ VG Thrombectomy Set - 106608-004, AngioJet™ Spiroflex™ Thrombectomy Set - 106553-004, AngioJet™ Solent™ Proxi Thrombectomy Set - 109676-004, AngioJet™ Solent™ Omni Thrombectomy Set - 109681-004, AngioJet™ PE Thrombectomy Set - 107171-003, AngioJet™ Distaflex™ Thrombectomy Set - 111304-003, AngioJet™ Solent™ Dista Thrombectomy Set - 111303-003, AngioJet™ ZelanteDVT™ Thrombectomy Set - 114610-002, AngioJet™ Ultra Power Pulse™ Kit - 104834-0030, AngioJet™ Ultra Power Pulse™ Kit - 104834-0031

Authorization date:

2012-02-20