Balt USA, LLC - FDA 510(k) Cleared Devices

Cleared Jul 13, 2026

SLIM Microcatheter

K260199 · QJP

Neurology · 172d

Cleared Apr 16, 2026

Next Generation 088 Catheter

K254223 · QJP

Neurology · 108d

Cleared Jan 27, 2026

Optima Coil System (OptiOne Coil System)

K254221 · HCG

Neurology · 29d

Cleared Oct 22, 2025

Carrier XL Delivery Catheter

K252569 · QJP

Neurology · 69d

Cleared Sep 26, 2025

Optima Coil System (Optima Packing Coil System)

K252700 · HCG

Neurology · 30d

Cleared Jun 03, 2025

Raptor Aspiration Catheter

K243948 · NRY

Neurology · 162d

Cleared Dec 30, 2024

Next Generation Access Platform

K242376 · QJP

Neurology · 143d

Cleared Sep 27, 2024

Optima Coil System (OptiBlock Line Extension)

K242582 · HCG

Neurology · 28d

Cleared Jul 02, 2024

Next Generation Access Catheter

K234074 · QJP

Neurology · 193d

Cleared Jul 02, 2024

Next Generation Aspiration Catheter

K234083 · NRY

Neurology · 193d

Cleared Sep 13, 2023

NG Delivery Catheter

K230609 · QJP

Neurology · 191d

Cleared Dec 06, 2022

Optima Coil System

K223386 · HCG

Neurology · 29d

Cleared Jul 19, 2022

MAGIC Flow-Dependent Microcatheter

K213435 · KRA

Neurology · 270d

Cleared Jan 29, 2021

MAGIC Infusion Catheter

K202366 · KRA

Neurology · 163d

Cleared Feb 01, 2020

Optima Coil System

K200030 · HCG

Neurology · 25d

Cleared Apr 30, 2019

Eclipse 2L

K183045 · MJN

Neurology · 179d

Cleared Mar 21, 2019

Ballast 088 Long Sheath

K182918 · DQY

Neurology · 153d

Cleared Oct 04, 2018

HYBRID Guidewire

K182337 · MOF

Neurology · 37d