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

Transcatheter Septal Occluder

Unknown
FDA source (opens on fda.gov)

MLV is the FDA product code for Transcatheter Septal Occluder, a class III device type. FDA's definition for this code reads: "Approved PMA: P000039". As of , FDA records hold no 510(k) clearances under this code and 15 recalls.

Classification record

Product code
MLV
Device name
Transcatheter Septal Occluder
FDA definition
Approved PMA: P000039
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
15

Companies listing this code with FDA

Companies whose registered establishments list this code