← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

OUT — Intracranial Aneurysm Flow Diverter

Treatment of wide-necked and larger or giant intracranial aneurysms.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P100018Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · pma2026-06-26
P170024Stryker Neurovascular · pma2026-06-26
P180027MicroVention, Inc. · pma2025-11-02

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →