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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 13 Results
ProductCode: GEI Applicant: BARRX MEDICAL, INCORPORATED Decision Date To: 03/28/2024
 
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barrx halo 360 system, model 1100c-115a BARRX MEDICAL, INCORPORATED K051168 06/29/2005
barrx halo coagulation system, barrx halo coagulation generator, barrx coagulation catheter, models 2200-115a, 1520f BARRX MEDICAL, INCORPORATED K060169 04/21/2006
halo coagulation catheter BARRX MEDICAL, INCORPORATED K062225 08/28/2006
halo90 coagulation catheter BARRX MEDICAL, INCORPORATED K062723 11/09/2006
barrx halo coagulation system; generator, model 90-9000; output cable, model 90-9010; footswitch, model 90-9020 BARRX MEDICAL, INCORPORATED K062441 11/14/2006
halo360' coagulation catheter BARRX MEDICAL, INCORPORATED K071543 06/29/2007
barrx models halo360 and halo360+ coagulation catheters BARRX MEDICAL, INCORPORATED K080557 04/02/2008
halo360 energy generator, models 1100c-115b and 1100c-230b BARRX MEDICAL, INCORPORATED K082202 10/08/2008
modification to: halo coagulation catheter, models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 BARRX MEDICAL, INCORPORATED K083711 02/02/2009
halo ablation catheter BARRX MEDICAL, INCORPORATED K083737 02/10/2009
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