510(k) K173834 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Quantum Pump Console
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, May 25, 2018 |
| Received | Dec 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2024 | Spectrum Medical Ltd. Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00 Completed |
DTQ | None listed |
| Aug 23, 2019 | Spectrum Medical Ltd. Quantum Pump Console Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.