510(k) K112360 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Sep 15, 2011 |
| Received | Aug 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112360
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2024 | Maquet Medical Systems USA Model No. BEQ-HLS 5050 USA,
HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine. Open, Classified |
DTZ | None listed |
| Feb 13, 2024 | Maquet Medical Systems USA BEQ-HLS 7050 USA,
HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine. Open, Classified |
DTZ | None listed |
| Feb 28, 2023 | Maquet Medical Systems USA BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077,
BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.
Part of the CARDIOHELP System, a pre-connected set used for extr Open, Classified |
DTZ | None listed |
| Jul 22, 2022 | Maquet Medical Systems USA BEQ-HLS 7050 USA;
HLS Set Advanced 7.0
Part No. 70105.2794.
A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. Open, Classified |
DTZ | None listed |
| Jul 22, 2022 | Maquet Medical Systems USA BEQ-HLS 5050 USA;
HLS Set Advanced 5.0
Part No. 70105.2797.
A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. Open, Classified |
DTZ | None listed |
| Jul 22, 2022 | Maquet Medical Systems USA BEQ-HLS 5050 USA;
HLS Set Advanced 5.0
Part No. 70106.9077.
A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. Open, Classified |
DTZ | None listed |
| Jul 22, 2022 | Maquet Medical Systems USA BEQ-HLS 7050 USA;
HLS Set Advanced 7.0
Part No. 70106.9078.
A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. Open, Classified |
DTZ | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Sep 20, 2013 | Maquet Cardiovascular Us Sales, Llc QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation d Terminated |
DTZ | None listed |
| Oct 26, 2012 | Maquet Cardiovascular Us Sales, Llc QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000
Product Usage:
The QUADROX oxygenators are intended for the use in extracor Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.