FDA Product Code
FDA Product Code BYS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4100
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232767 | Nautilus VF ECMO Oxygenator | Mc3, Inc. | 2023-10-04 | Special | PDF ↗ |
| K191935 | Nautilus Smart ECMO Module | Mc3 Incorporated | 2020-04-09 | Traditional | PDF ↗ |
| K770720 | TUBING PACK, EXTRACORPOREAL, H-3000 | William Harvey Life Products Corp. | 1977-08-04 | Traditional | PDF ↗ |
Product code BYS · Class II · Cardiovascular. Data: openFDA.