Tubing, Long Term Support Greater Than 6 Hours
The long-term support tubing (greater than 6 hours) for extracorporeal membrane oxygenation (product code QWF) is used to connect perfusion devices and circulate blood as part of ECMO procedures lasting longer than 6 hours. Classified as Class 2 in the Cardiovascular specialty (regulation 870.4100), it requires 510(k) clearance. This device is designated as life-sustaining, reflecting its critical role in supporting patients dependent on extracorporeal circulation. It is not an implant.
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Basic Information
- Product Code
- QWF
- Device Class
- FDA class 2
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface | Apr 19, 2023 | Substantially Equivalent | Medtronic, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.