510(k) Clearance for AngioJet AVX Thrombectomy Catheter
April 7, 2014 — Bayer Radiology and Interventional (Indianola, PA) widens its portfolio of solutions for restoring flow by announcing it recently received 510(k) clearance from the US Food and Drug Administration for its AngioJet® AVX Thrombectomy catheter with the added ability of contrast injection. The 6 French, 50cm length AVX Thrombectomy set now allows injection of contrast via the manifold for evaluation of treatment offering speed and versatility for declot of AV access grafts and fistulas. The AngioJet System is indicated for breakup and removal of thrombus from AV access conduits and coronary arteries, as well as peripheral arteries and veins. Removal of thrombus reduces the need for thrombolytics. www.ri.bayer.com
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