FDA.reportPublic FDA data

Neurovascular embolization plug

Definition
A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.
GUDID devices
21
Last updated
2026-07-17 21:59:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840303707295SQUID Liquid Embolic AgentBALT USA LLCSQUID12KIT2026-06-23
00840303713173SQUID Liquid Embolic AgentBALT USA LLCSQUID12LDKIT2026-06-23
00840303713180SQUID Liquid Embolic AgentBALT USA LLCSQUID18KIT2026-06-23
00840303713197SQUID Liquid Embolic AgentBALT USA LLCSQUID18LDKIT2026-06-23
00840303713265SQUID Liquid Embolic AgentBALT USA LLCSQUID34KIT2026-06-23
00840303713272SQUID Liquid Embolic AgentBALT USA LLCSQUID34LDKIT2026-06-23
00840303713289SQUID Liquid Embolic AgentBALT USA LLCSQUID123MLKIT2026-06-23
00840303713296SQUID Liquid Embolic AgentBALT USA LLCSQUID12LD3MLKIT2026-06-23
00840303713302SQUID Liquid Embolic AgentBALT USA LLCSQUID183MLKIT2026-06-23
00840303713319SQUID Liquid Embolic AgentBALT USA LLCSQUID18LD3MLKIT2026-06-23
00840303713326SQUID Liquid Embolic AgentBALT USA LLCSQUID343MLKIT2026-06-23
00840303713333SQUID Liquid Embolic AgentBALT USA LLCSQUID34LD3MLKIT2026-06-23
00199150045532OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.105-7100-0602026-06-07
00836462005129Onyx HD 500Micro Therapeutics, Inc.105-8101-5002014-09-22
00199150045549OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.105-7100-0802026-06-01
00763000925338OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.105-7100-0602026-01-02
00763000925352OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.105-7100-0802026-01-02
10886704085317TRUFILLCerenovus, Inc.632500NA2023-10-23
10886704085324TRUFILLCerenovus, Inc.632400NA2023-10-23
10886704029144TRUFILLCerenovus, Inc.631-4002014-09-20
10886704029151TRUFILLCerenovus, Inc.631-5002014-09-20