Product code QWF
- Device name
- Tubing, Long Term Support Greater Than 6 Hours
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4100
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceĀ Biosurface | Medtronic, Inc. | 2023-04-19 |