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

Intrasaccular Flow Disruption Device

Unknown
FDA source (opens on fda.gov)

OPR is the FDA product code for Intrasaccular Flow Disruption Device, a class III device type. FDA's definition for this code reads: "An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OPR
Device name
Intrasaccular Flow Disruption Device
FDA definition
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
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
1

Companies listing this code with FDA

Companies whose registered establishments list this code