Multi-Lumen Hemodialysis Catheterization Kit
The Multi-Lumen Hemodialysis Catheterization Kit is a convenience kit containing a multi-lumen catheter and associated supplies used to establish hemodialysis access, allowing simultaneous blood withdrawal and return through separate lumens. It falls under FDA Class 2 in the Gastroenterology and Urology specialty, regulated under 21 CFR 876.5540. 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 PPO; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPO
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- 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 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.