Balt USA, LLC
FDA 510(k) & PMA Approved Devices — 20 products
Total Devices20
Categories9
Latest FDA decision2026-07-13
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260199 | SLIM Microcatheter | QJP | 2026-07-13 | View |
| 510(k) | K254223 | Next Generation 088 Catheter | QJP | 2026-04-16 | View |
| PMA | P250009 | Neurovascular Liquid Embolic Agent | SGU | 2026-01-30 | View |
| 510(k) | K254221 | Optima Coil System (OptiOne Coil System) | HCG | 2026-01-27 | View |
| 510(k) | K252569 | Carrier XL Delivery Catheter | QJP | 2025-10-22 | View |
| 510(k) | K252700 | Optima Coil System (Optima Packing Coil System) | HCG | 2025-09-26 | View |
| 510(k) | K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2025-06-03 | View |
| 510(k) | K251383 | Prestige Coil System (Prestige Packing Line Extension) | KRD | 2025-05-30 | View |
| 510(k) | K242376 | Next Generation Access Platform | QJP | 2024-12-30 | View |
| 510(k) | K242582 | Optima Coil System (OptiBlock Line Extension) | HCG | 2024-09-27 | View |
| 510(k) | K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2024-07-02 | View |
| 510(k) | K234074 | Next Generation Access Catheter | QJP | 2024-07-02 | View |
| 510(k) | K230609 | NG Delivery Catheter | QJP | 2023-09-13 | View |
| 510(k) | K223386 | Optima Coil System | HCG | 2022-12-06 | View |
| 510(k) | K213435 | MAGIC Flow-Dependent Microcatheter | KRA | 2022-07-19 | View |
| 510(k) | K202366 | MAGIC Infusion Catheter | KRA | 2021-01-29 | View |
| 510(k) | K200030 | Optima Coil System | HCG | 2020-02-01 | View |
| 510(k) | K183045 | Eclipse 2L | MJN | 2019-04-30 | View |
| 510(k) | K182918 | Ballast 088 Long Sheath | DQY | 2019-03-21 | View |
| 510(k) | K182337 | HYBRID Guidewire | MOF | 2018-10-04 | View |
No matching devices.