QWF — Tubing, Long Term Support Greater Than 6 Hours Class II
FDA product code QWF covers "Tubing, Long Term Support Greater Than 6 Hours", a Class II medical device regulated under 21 CFR 870.4100. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWF
- Device Class
- Class II
- Regulation Number
- 870.4100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223168 | medtronic | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with | April 19, 2023 |