510(k) K102726 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
CARDIOHELP SYSTEM
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Apr 4, 2011 |
| Received | Sep 21, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Maquet Cardiopulmonary Ag Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. Open, Classified |
DTQ | None listed |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iR, used during cardiopulmonary bypass
Model Item No. Description
BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOL Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-iR, used during cardiopulmonary bypass
Model Item No. Description
BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating
BE Open, Classified |
DTQ | 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 | None listed |
| Apr 4, 2018 | Maquet Cardiopulmonary Ag 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 require Terminated |
KRI | None listed |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc HLS Set Advanced with BIOLINE Coating
Custom tubing packs for the oxygenator Terminated |
DTQ | None listed |
| 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 | None listed |
| Nov 13, 2014 | Maquet Cardiovascular Us Sales, Llc Cardiohelp-I System
Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support durin Terminated |
DTQ | None listed |
| Oct 25, 2013 | Maquet Medical Systems USA MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany.
Cardiopulmonary support system. Terminated |
DTQ | None listed |
| Apr 18, 2013 | Maquet Cardiovascular, LLC MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)
Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood thro Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.