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Intracranial Coil-Assist Stent

FDA product code QCA · Class 3 · Unknown

54
Registered devices
806
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-04-06MICROVENTION INC.Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is ov
2024-12-11MICROVENTION INC.Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.