MAQUET CARDIOPULMONARY GmbH
Rastatt Baden-Wurttemberg, DE
MAQUET CARDIOPULMONARY GmbH appears in FDA device records in Rastatt Baden-Wurttemberg, DE. FDA records list 44 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 44 510(k) clearances for MAQUET CARDIOPULMONARY GmbH between 2005 and 2015. The busiest year on record is 2009, with 12. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 5 |
| 2007 | 1 |
| 2008 | 6 |
| 2009 | 12 |
| 2010 | 2 |
| 2011 | 6 |
| 2013 | 7 |
| 2014 | 3 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | DTZ | Substantially Equivalent | |
| K140569 | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) | DWF | Substantially Equivalent | |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | DTN | Substantially Equivalent | |
| K133598 | CARDIOHELP SYSTEM | DTQ | Substantially Equivalent | |
| K133265 | QUADROX-IR ADULT AND SMALL ADULT | KFM | Substantially Equivalent | |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | DTN | Substantially Equivalent | |
| K132829 | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS | DTZ | Substantially Equivalent | |
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | DWF | Substantially Equivalent | |
| K130300 | HEATER-COOLER UNIT HCU 40 | DWC | Substantially Equivalent | |
| K123288 | HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K130639 | ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER | DWF | Substantially Equivalent | |
| K112360 | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES | DTZ | Substantially Equivalent | |
| K102726 | CARDIOHELP SYSTEM | DTQ | Substantially Equivalent | |
| K102919 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE | DTN | Substantially Equivalent | |
| K103191 | QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING | DTZ | Substantially Equivalent | |
| K102464 | QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING | DTZ | Substantially Equivalent | |
| K102532 | HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | DWF | Substantially Equivalent | |
| K101153 | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD | DTZ | Substantially Equivalent | |
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA | DTZ | Substantially Equivalent | |
| K090690 | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | DTN | Substantially Equivalent | |
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | DTR | Substantially Equivalent | |
| K090534 | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | DTN | Substantially Equivalent | |
| K090533 | HLM TUBING SET WITH SOFTLINE COATING | DWF | Substantially Equivalent | |
| K090518 | QUART ARTERIAL FILTER WITH SOFTLINE COATING | DTM | Substantially Equivalent | |
| K090515 | ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) | KFM | Substantially Equivalent | |
| K093522 | QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C | DTZ | Substantially Equivalent | |
| K090689 | QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 | DTZ | Substantially Equivalent | |
| K090511 | QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 | DTZ | Substantially Equivalent | |
| K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 | DRY | Substantially Equivalent | |
| K083794 | MECC SET WITH BIOLINE COATING | KFM | Substantially Equivalent | |
| K082117 | QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 | DTZ | Substantially Equivalent | |
| K082544 | QUART ARTERIAL FILTER WITH BIOLINE COATING | DTM | Substantially Equivalent | |
| K080470 | ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 | KFM | Substantially Equivalent | |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | DWE | Substantially Equivalent | |
| K072583 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | DTR | Substantially Equivalent | |
| K071774 | JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 | DTZ | Substantially Equivalent | |
| K070605 | JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING | DTN | Substantially Equivalent | |
| K072172 | JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE | DWF | Substantially Equivalent | |
| K061628 | JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 | DTZ | Substantially Equivalent | |
| K061832 | JOSTRA HLM TUBING SETS WITH SAFELINE COATING | DWF | Substantially Equivalent | |
| K061743 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 | DTN | Substantially Equivalent | |
| K061546 | QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 | DTM | Substantially Equivalent | |
| K061072 | ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 | KFM | Substantially Equivalent | |
| K053025 | JOSTRA HLM TUBING SET | DWE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009507273 | 3009507273 | MAQUET CARDIOPULMONARY GmbH | Kehler Strasse 31, Rastatt Baden-Wurttemberg 76437 DE | 2026 | |
| 8010762 | 3009649876 | MAQUET CARDIOPULMONARY GmbH | Neue Rottenburger Strasse 37, Hechingen Baden-Wurttemberg 72379 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DWCController, Temperature, Cardiopulmonary Bypass
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- DREDilator, Vessel, For Percutaneous Catheterization
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DPWFlowmeter, Blood, Cardiovascular
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- DWETubing, Pump, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1300-2026 | Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; | Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised. | Class II | Open, Classified | |
| Z-2193-2025 | Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags. | Device does not comply with the labeling requirements of international standard IEC 60601-1. | Class II | Open, Classified | |
| Z-1823-2025 | Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. | Class II | Open, Classified | |
| Z-2161-2018 | Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | Class II | Terminated | |
| Z-2160-2018 | Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | Class II | Terminated | |
| Z-2159-2018 | Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | Class II | Terminated | |
| Z-1642-2018 | CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft. | There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain