510(k) K190282 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, May 24, 2019 |
| Received | Feb 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190282
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.