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Balt USA, LLC FDA Approvals
0 new drug approvals and 15 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| SLIM Microcatheter510(k)Jul 13, 2026Cardiovascular |
| Next Generation 088 Catheter510(k)Apr 16, 2026Cardiovascular |
| Optima Coil System (OptiOne Coil System)510(k)Jan 27, 2026Neurology |
| Carrier XL Delivery Catheter510(k)Oct 22, 2025Cardiovascular |
| Optima Coil System (Optima Packing Coil System)510(k)Sep 26, 2025Neurology |
| Raptor Aspiration Catheter; Balt Aspiration Tubing Set510(k)Jun 3, 2025Cardiovascular |
| Prestige Coil System (Prestige Packing Line Extension)510(k)May 30, 2025Cardiovascular |
| Next Generation Access Platform510(k)Dec 30, 2024Cardiovascular |
| Optima Coil System (OptiBlock Line Extension)510(k)Sep 27, 2024Neurology |
| Next Generation Access Catheter510(k)Jul 2, 2024Cardiovascular |
| Next Generation Aspiration Catheter; Balt Aspiration Tubing Set510(k)Jul 2, 2024Cardiovascular |
| NG Delivery Catheter510(k)Sep 13, 2023Cardiovascular |
| Optima Coil System510(k)Dec 6, 2022Neurology |
| MAGIC Flow-Dependent Microcatheter510(k)Jul 19, 2022Cardiovascular |
| MAGIC Infusion Catheter510(k)Jan 29, 2021Cardiovascular |