Panels › Cardiovascular › Product code DXG · Class 2
Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation 870.1435
1510(k)s in 12 months (177 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in DXG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2020 | Lidco Ltd CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set). Terminated |
DXG | K163334 |
| Nov 9, 2020 | ICU Medical, Inc. icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diag Terminated |
DXG | K152006 |
| Feb 14, 2020 | ICU Medical, Inc. The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intende Terminated |
DXG | K152006 |
| Jun 5, 2019 | GETINGE US SALES LLC PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.
Usage:
The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monit Terminated |
DXG | K172259 |
| Apr 18, 2013 | Transonic Systems Inc HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only.
Product Usage: is indicated for use in patients greater than or Terminated |
DXG | K080116 |
| Feb 2, 2012 | Edwards Lifesciences, Llc Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69,
00.71, 00.73.
Product Usage:
The Vigilance II CCO/SvO2/CEDV Monitor is indicated for Terminated |
DXG | K043103 |
| Oct 28, 2010 | Edwards Lifesciences, Llc Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001
The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vig Terminated |
DXG | K060660 |
| Nov 9, 2009 | Hospira Inc Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04- Terminated |
DXG | K932414 |
| Nov 9, 2009 | Hospira Inc Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 56711-04-03, 5671-04-05, 56711-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufa Terminated |
DXG | K932414 |
| Nov 9, 2009 | Hospira Inc Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pu Terminated |
DXG | K932414 |
| Nov 9, 2009 | Hospira Inc Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
DXG | K853018 |
| Nov 9, 2009 | Hospira Inc Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer, List Number 50132-04-05, AC cord manufactured by Electri Terminated |
DXG | K853018 |
| Nov 9, 2009 | Hospira Inc Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
DXG | K932414 |
| Nov 24, 2007 | Edwards Lifesciences, Llc Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifescien Terminated |
DXG | K043103 |
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