Balt USA, LLC - FDA 510(k) Cleared Devices
Recent clearances: SLIM Microcatheter, Next Generation 088 Catheter, Optima Coil System (OptiOne Coil System)
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Balt USA, LLC Neurology ✕
18 devices
Cleared
Jul 13, 2026
SLIM Microcatheter
Neurology
172d
Cleared
Apr 16, 2026
Next Generation 088 Catheter
Neurology
108d
Cleared
Jan 27, 2026
Optima Coil System (OptiOne Coil System)
Neurology
29d
Cleared
Oct 22, 2025
Carrier XL Delivery Catheter
Neurology
69d
Cleared
Sep 26, 2025
Optima Coil System (Optima Packing Coil System)
Neurology
30d
Cleared
Jun 03, 2025
Raptor Aspiration Catheter
Neurology
162d
Cleared
Dec 30, 2024
Next Generation Access Platform
Neurology
143d
Cleared
Sep 27, 2024
Optima Coil System (OptiBlock Line Extension)
Neurology
28d
Cleared
Jul 02, 2024
Next Generation Access Catheter
Neurology
193d
Cleared
Jul 02, 2024
Next Generation Aspiration Catheter
Neurology
193d
Cleared
Sep 13, 2023
NG Delivery Catheter
Neurology
191d
Cleared
Dec 06, 2022
Optima Coil System
Neurology
29d
Cleared
Jul 19, 2022
MAGIC Flow-Dependent Microcatheter
Neurology
270d
Cleared
Jan 29, 2021
MAGIC Infusion Catheter
Neurology
163d
Cleared
Feb 01, 2020
Optima Coil System
Neurology
25d
Cleared
Apr 30, 2019
Eclipse 2L
Neurology
179d
Cleared
Mar 21, 2019
Ballast 088 Long Sheath
Neurology
153d
Cleared
Oct 04, 2018
HYBRID Guidewire
Neurology
37d