Intrasaccular Flow Disruption Device

OPR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OPR
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: NE
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 6

Source

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