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

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Unknown
FDA source (opens on fda.gov)

PHO is the FDA product code for Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs, a class III device type. FDA's definition for this code reads: "Preservation of donor lungs for transplantation". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PHO
Device name
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA definition
Preservation of donor lungs for 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