Company ยท US
Mc3 Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 2023 | K232767 | Nautilus VF ECMO Oxygenator Mc3, Inc. | BYS |
| May 3, 2021 | K203409 | MC3 Crescent Jugular Dual Lumen Catheter Mc3, Inc. | PZS |
| Apr 9, 2020 | K191935 | Nautilus Smart ECMO Module Mc3 Incorporated | BYS |
| Oct 29, 2018 | K182914 | MC3 Vascular Access Kit 21030 Mc3 Incorporated | DRE |
| Jul 16, 2018 | K180151 | MC3 Jugular Dual Lumen Catheter Mc3 Incorporated | PZS |
| Nov 16, 2017 | K171610 | MC3 QuickFlow Dual Lumen Catheter Mc3 Incorporated | PZS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Mc3 Inc NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature.
Product Number: 48135, 48 Open, Classified |
BYS | K191935 |
| Mar 19, 2024 | Mc3 Inc NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature.
Product Number: (1) 48145; Open, Classified |
BYS | K191935 |