K200683 is an FDA 510(k) clearance for the INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 12, 2020, 88 days after receiving the submission on March 16, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K200683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2020 |
| Decision Date | June 12, 2020 |
| Days to Decision | 88 days |
| Submission Type | Special |
| 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 |