Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Neurovascular Liquid Embolic Agent

PMA Number: P250009 · 2026-09-09

ApplicantBalt USA, LLC
Decision Date2026-09-09
PMA NumberP250009
Product CodeSGU
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

Neurovascular Liquid Embolic Agent is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2026-09-09. The device is classified under product code SGU. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Neurovascular Liquid Embolic Agent?

Neurovascular Liquid Embolic Agent is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is Balt USA, LLC.

When did Neurovascular Liquid Embolic Agent receive FDA 510(k) clearance?

The clearance date for Neurovascular Liquid Embolic Agent can be found in the official FDA records.

Who is the listed applicant for Neurovascular Liquid Embolic Agent?

The FDA 510(k) record lists Balt USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neurovascular Liquid Embolic Agent?

The FDA product code for Neurovascular Liquid Embolic Agent is SGU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑