FDA Product Code
FDA Product Code QWF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4100
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface | Medtronic, Inc. | 2023-04-19 | Traditional | PDF ↗ |
Product code QWF · Class II · Cardiovascular. Data: openFDA.