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SQUID Liquid Embolic Agent (LEA)

FDA PMA

Class III (US FDA PMA)

PMA P250009

by Balt Usa Llc

Identity

Trade Name
SQUID Liquid Embolic Agent (LEA) FDA PMA
Generic Name
Neurovascular Liquid Embolic Agent FDA PMA

Identifiers

PMA Number
P250009 FDA PMA
FDA Product Code
SGU FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Neurology FDA PMA
FDA Decision
APPR Approved FDA PMA

The SQUID Liquid Embolic Agent (LEA) is a neurovascular liquid embolic agent designed for embolization procedures. It is classified as a Class III medical device under FDA regulations and is intended for use in vascular interventions within the neurovascular system.

This agent is supplied as a sterile, single-use product and is used in conjunction with neurosurgical assessment to treat symptomatic chronic subdural hematomas (SDH) measuring 10 mm or greater in thickness. It is administered via embolization of the middle meningeal artery (MMA) as an adjunct to standard care. The device holds a Premarket Approval (PMA) from the FDA under PMA number P250009.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Balt Usa Llc
FDA Applicant
Balt USA, LLC

Sources (1)

  • FDA PMA P250009 24 fields · synced Sep 18, 2026