Maquet Cardiopulmonary, AG
Maquet Cardiopulmonary, AG holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2015, with 5 FDA device recalls on record.
Top product codes for Maquet Cardiopulmonary, AG
FDA recalls by Maquet Cardiopulmonary, AG
- Z-1823-2025 — Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- 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
- 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
- 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
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Maquet Cardiopulmonary, AG
- K150267 — QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators
- K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
- K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- K133598 — CARDIOHELP SYSTEM
- K133265 — QUADROX-IR ADULT AND SMALL ADULT
- K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
- K132829 — QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
- K131666 — ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
- K130300 — HEATER-COOLER UNIT HCU 40
- K123288 — HEMOCONCENTRATOR
- K130639 — ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
- K112360 — QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
- K102726 — CARDIOHELP SYSTEM
- K102919 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
- K103191 — QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
- K102464 — QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
- K102532 — HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
- K101153 — QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
- K100278 — QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
- K090534 — VENOUS HARDSHELL CARDIOTOMY RESERVIORS
- K090555 — PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
- K090690 — VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
- K090515 — ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
- K090518 — QUART ARTERIAL FILTER WITH SOFTLINE COATING
- K090533 — HLM TUBING SET WITH SOFTLINE COATING
- K093522 — QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
- K090689 — QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
- K090511 — QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
- K090147 — BLOOD MONITORING UNIT, MODEL BMU 40
- K083794 — MECC SET WITH BIOLINE COATING
- K082117 — QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
- K082544 — QUART ARTERIAL FILTER WITH BIOLINE COATING
- K080470 — ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
- K080592 — HLM TUBING SET WITH BIOLINE COATING
- K072583 — PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
- K071774 — JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
- K070605 — JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
- K072172 — JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
- K061628 — JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
- K061832 — JOSTRA HLM TUBING SETS WITH SAFELINE COATING
- K061743 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000; VACUUM TIGHT, MODEL BSQ-VHK 2001
- K061546 — QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
- K061072 — ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
- K053025 — JOSTRA HLM TUBING SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.