Polymerizing, Neurovascular Embolization Material

OBA · f · Unknown

Classification

FDA Product Code: OBA
Device class: f
Regulation: —
Review panel: NE
Medical specialty: Unknown
Submission type: 6
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

Definition

The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown