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

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Unknown
FDA source (opens on fda.gov)

QQK is the FDA product code for Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation, a class III device type. FDA's definition for this code reads: "The device is intended for machine preservation of donor livers prior to transplantation". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QQK
Device name
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA definition
The device is intended for machine preservation of donor livers prior to transplantation.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code