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

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

Unknown
FDA source (opens on fda.gov)

NPE is the FDA product code for Material, Embolization, Neurovascular, Polymerizing Or Precipitating, a class III device type. FDA's definition for this code reads: "This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
NPE
Device name
Material, Embolization, Neurovascular, Polymerizing Or Precipitating
FDA definition
This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.
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

No registered establishment in MDM’s records lists product code NPE.