Company
Maquet Cardiovascular Us Sales, Llc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
64recalls (0 in 12 months)
48recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTD | Lamp, Surgical | 13 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 11 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 5 |
| FQO | Table, Operating-Room, Ac-Powered | 5 |
| MEC | Disinfector, Medical Devices | 5 |
| BSZ | Gas-Machine, Anesthesia | 4 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 4 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 |
| FWZ | Operating Room Accessories Table Tray | 2 |
| LGX | Table, Examination, Medical, Powered | 2 |
| BTI | Compressor, Air, Portable | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| CBN | Apparatus, Gas-Scavenging | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| FGY | Cannula, Injection | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2020 | Maquet Cardiovascular Us Sales, Llc HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorpore Terminated |
DTZ | K112360 |
| Nov 20, 2020 | Maquet Cardiovascular Us Sales, Llc HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extraco Terminated |
DTZ | K112360 |
| Sep 30, 2020 | Maquet Cardiovascular Us Sales, Llc Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which req Terminated |
DRY | K090147 |
| Sep 24, 2020 | Maquet Cardiovascular Us Sales, Llc Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
Part 143302F0 (US Terminated |
FQO | None listed |
| Sep 24, 2020 | Maquet Cardiovascular Us Sales, Llc Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
Part 14 Terminated |
FQO | None listed |
| Aug 7, 2020 | Maquet Cardiovascular Us Sales, Llc Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood Terminated |
KFM | K991864 |
| Jun 18, 2020 | Maquet Cardiovascular Us Sales, Llc Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal Terminated |
KRI | None listed |
| Feb 20, 2020 | Maquet Cardiovascular Us Sales, Llc Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 Terminated |
DRE | K081940 |
| Feb 18, 2020 | Maquet Cardiovascular Us Sales, Llc Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying
Model Number: 88-5
Part Number: 88-103; 88-203 Terminated |
MEC | None listed |
| Jan 16, 2020 | Maquet Cardiovascular Us Sales, Llc Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or h Terminated |
MEC | None listed |
| Jan 16, 2020 | Maquet Cardiovascular Us Sales, Llc Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or h Terminated |
MEC | None listed |
| Dec 3, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. Terminated |
KFM | K991864 |
| Jul 11, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794 Terminated |
DTZ | K112360 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229037A
Model: VST66DF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229036A
Model:VST66SF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229035A
Model:VST60DF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229034A
Model: VST60SF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229003A
Model: VST66DF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229002A
Model: VST66SF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229001A
Model: VST60DF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229000A
Model: VST60SF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568812910
Model: VLT400SF STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811961 Model: VLT600DF AIM STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811911
Model: VLT600SF AIM STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811910
Model:VLT600SF STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811901
Model: VLT600SF AIM STP Terminated |
FTD | K130513 |
| Jun 4, 2019 | Maquet Cardiovascular Us Sales, Llc GETINGE MEERA MOBILE OPERATING TABLE:
(1) Part 720001B2
(2) Part 720001B0
(3) Part 720001F2
(4) Part 720001F0
(5) Part 710001B2
(6) Part 710001B0
(7) Part 710001F0
Product Usage:
The Meera Mob Terminated |
LGX | None listed |
| May 20, 2019 | Maquet Cardiovascular Us Sales, Llc Getinge 86-Series-Medical Washer-Disinfector
Part Number: S-86682003
Product Usage:
The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories w Terminated |
MEC | None listed |
| May 20, 2019 | Maquet Cardiovascular Us Sales, Llc Getinge 86-Series-Medical Washer-Disinfector
Part Number: S-86662003
Product Usage: Usage:
The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laborat Terminated |
MEC | None listed |
| Mar 28, 2019 | Maquet Cardiovascular Us Sales, Llc Cardiohelp Emergency Drive, Part No. 70104.8002
Product Usage:
The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails. Terminated |
DTQ | K102726 |
| Nov 28, 2018 | Maquet Cardiovascular Us Sales, Llc QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207
The membrane oxygenator QUADROXi Neonatal is intended for use in ext Terminated |
DTZ | K102464 K141432 |
| Nov 28, 2018 | Maquet Cardiovascular Us Sales, Llc QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120
The membrane oxygenator QUADROXi Neonatal is intended for use in Terminated |
DTZ | K102464 K141432 |
| Sep 27, 2016 | Maquet Cardiovascular Us Sales, Llc Heater Cooler Unit
Usage:
The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for b Terminated |
DWC | K031544 |
| Aug 12, 2016 | Maquet Cardiovascular Us Sales, Llc The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical i Terminated |
FQO | None listed |
| Mar 3, 2016 | Maquet Cardiovascular Us Sales, Llc Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH,
Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device Terminated |
FQO | None listed |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc Custom Tubing Packs
Custom tubing pack for oxygenators Terminated |
KFM | K080592 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc Rotaflow Centrifugal Pump
Custom tubing packs for the oxygenator Terminated |
KFM | K080470 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc HLS Set Advanced with BIOLINE Coating
Custom tubing packs for the oxygenator Terminated |
DTQ | K102726 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc QUADROX-i oxygenators
Custom tubing packs for the oxygenator Terminated |
DTZ | K082117 K090689 +4 |
| Feb 22, 2016 | Maquet Cardiovascular Us Sales, Llc Flow-i Anesthesia System
Product Usage:
The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to Terminated |
BSZ | K133958 |
| Jan 5, 2016 | Maquet Cardiovascular Us Sales, Llc Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W
Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or coo Terminated |
DWC | K031544 |
| Nov 9, 2015 | Maquet Cardiovascular Us Sales, Llc Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany
The MAQUET Adjustable Positioning Elements are designed for the placement and positioning Terminated |
FWZ | None listed |
| Nov 9, 2015 | Maquet Cardiovascular Us Sales, Llc Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners.
The MAQUET Adjustable Positioning Elements are designed for the placement an Terminated |
FWZ | None listed |
| Jul 17, 2015 | Maquet Cardiovascular Us Sales, Llc Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co. Terminated |
FQO | None listed |
| Jul 15, 2015 | Maquet Cardiovascular Us Sales, Llc The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847
FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire Terminated |
BSZ | K133958 |
| Jul 7, 2015 | Maquet Cardiovascular Us Sales, Llc The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems Terminated |
FSY | K040735 K070442 +1 |
| Jun 8, 2015 | Maquet Cardiovascular Us Sales, Llc FLOW-i Anesthesia System
The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations. Terminated |
BSZ | K133958 |
| May 28, 2015 | Maquet Cardiovascular Us Sales, Llc HLS/HIT Set Advanced with Bioline and/or Softline Coating Console
Product Usage:
HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used wi Terminated |
DTQ | K102726 |
| May 28, 2015 | Maquet Cardiovascular Us Sales, Llc Quadrox-iD Adult Diffusion Membrane Oxygenator
Product Usage:
The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in Terminated |
DTZ | K132829 |
| Feb 27, 2015 | Maquet Cardiovascular Us Sales, Llc Servo-I ventilator system CO2 analyzer. Part number 65 23 588. Terminated |
CBN | K123149 |
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