K190282 is an FDA 510(k) clearance for the Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand). This device is classified as a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II - Special Controls, product code DTQ).
Submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on May 24, 2019, 102 days after receiving the submission on February 11, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4220.
| 510(k) Number | K190282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | May 24, 2019 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTQ - Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4220 |