K180950 is an FDA 510(k) clearance for the Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation). This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on June 22, 2018, 72 days after receiving the submission on April 11, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K180950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2018 |
| Decision Date | June 22, 2018 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |