FDA 510(k) Applications Submitted by Brit Baird

FDA 510(k) Number Submission Date Device Name Applicant
K120242 01/27/2012 JETSTREAM NAVITUS L SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC.
K090325 02/09/2009 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) PATHWAY MEDICAL TECHNOLOGIES, INC.
K100462 02/18/2010 JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 PATHWAY MEDICAL TECHNOLOGIES, INC.
K130637 03/11/2013 JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM MEDRAD, INC.
K191000 04/16/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc
K091509 05/22/2009 JETSTREAM G2 NXT SYSTEM, MODEL PV20300 PATHWAY MEDICAL TECHNOLOGIES, INC.
K191471 06/03/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc
K172035 07/05/2017 EKOS ultrasound EVD Device, EVD Control Unit BTG International, Inc.
K122916 09/21/2012 JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM MEDRAD, INC.
K093918 12/22/2009 JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) PATHWAY MEDICAL TECHNOLOGIES, INC.


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