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

Valve, Pulmonary

Unknown
FDA source (opens on fda.gov)

NJK is the FDA product code for Valve, Pulmonary, a class III device type. FDA's definition for this code reads: "To improve lung function in patients with emphysema". As of , FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code
NJK
Device name
Valve, Pulmonary
FDA definition
To improve lung function in patients with emphysema
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
3

Companies listing this code with FDA

Companies whose registered establishments list this code