510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PINClass II

Kidney Perfusion Kit

21 CFR 876.5880 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PIN is the FDA product code for Kidney Perfusion Kit, a class II device type, regulated under 21 CFR 876.5880. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PIN
Device name
Kidney Perfusion Kit
FDA 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.
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code