Kidney Perfusion Kit
The Kidney Perfusion Kit is a convenience kit used in kidney perfusion procedures, established under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance. It is an FDA Class 2 device regulated under 21 CFR 876.5880, subject to enforcement discretion and not requiring a premarket notification (510(k)) to market if all guidance criteria are met. The product code is PIN, within the Gastroenterology and Urology (GU) specialty. This kit is not an implant and is not life-sustaining.
Research product code PIN in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PIN
- Device Class
- FDA class 2
- Regulation Number
- 876.5880
- 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.