Nautilus Smart ECMO Module— 510(k) K191935
Substantially EquivalentMc3 Incorporated
FDA 510(k) clearance K191935 for Nautilus Smart ECMO Module, Substantially Equivalent on 2020-04-09. Applicant: Mc3 Incorporated. Device class: 2.
Clearance details
- Applicant
- Mc3 Incorporated
- Product code
- Code BYS
- Device class
- Class 2
- Regulation
- 21 CFR 870.4100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dexter, MI, US
Recent devices under product code BYS
view allMore clearances from Mc3 Incorporated
view allAdverse events under product code BYS
product code BYS- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K191935
K-number listed on FDA's recall record- Z-1309-2024 — 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; (2) 48145E
- Z-1310-2024 — 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, 48135E
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191935.
Data sourced from openFDA. This site is unofficial and independent of the FDA.