Single Needle (Co-Axial Flow) Dialysis Kit
The Single Needle (Co-Axial Flow) Dialysis Kit is a convenience kit used in hemodialysis where a single needle provides both blood withdrawal and return via a coaxial flow design, bundled with associated supplies. It falls under FDA Class 2 in the Gastroenterology and Urology specialty, regulated under 21 CFR 876.5820. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PPL; not an implant and not life-sustaining.
Basic Information
- Product Code
- PPL
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.