QWF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tubing, Long Term Support Greater Than 6 Hours
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- FDA definition
- The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface (K223168) | Medtronic, Inc. | 2023-04-19 | + Add |
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