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Barrx Medical, Incorporated

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K093855 HALO 360 & SIZING BALLOON, MODEL 3441CGEI2010-01-15 View
510(k) K093008 HALO ABLATION CATHETER, MODEL 90-9100GEI2010-01-08 View
510(k) K092487 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230AGEI2009-11-10 View
510(k) K083737 HALO ABLATION CATHETERGEI2009-02-10 View
510(k) K083711 MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34GEI2009-02-02 View
510(k) K082202 HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230BGEI2008-10-08 View
510(k) K080557 BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERSGEI2008-04-02 View
510(k) K071543 HALO360' COAGULATION CATHETERGEI2007-06-29 View
510(k) K062441 BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020GEI2006-11-14 View
510(k) K062723 HALO90 COAGULATION CATHETERGEI2006-11-09 View
510(k) K062225 HALO COAGULATION CATHETERGEI2006-08-28 View
510(k) K060169 BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520FGEI2006-04-21 View
510(k) K051168 BARRX HALO 360 SYSTEM, MODEL 1100C-115AGEI2005-06-29 View
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