BALT USA, LLC
Summary
- Total Recalls
- 8 (1 Class I)
- 510(k) Clearances
- 17
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0188-2026 | Class I | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: M | September 25, 2025 |
| Z-1988-2025 | Class II | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0 | May 8, 2025 |
| Z-1989-2025 | Class II | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 0081006856766 | May 8, 2025 |
| Z-1041-2024 | Class II | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are ins | January 3, 2024 |
| Z-1042-2024 | Class II | The Prestige Coil System is a product family of embolic coils with associated delivery system compon | January 3, 2024 |
| Z-0103-2023 | Class II | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovasc | September 7, 2022 |
| Z-1680-2022 | Class II | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. | July 26, 2022 |
| Z-0660-2022 | Class II | The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten | January 4, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K254221 | Optima Coil System (OptiOne Coil System) | January 27, 2026 |
| K252569 | Carrier XL Delivery Catheter | October 22, 2025 |
| K252700 | Optima Coil System (Optima Packing Coil System) | September 26, 2025 |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | June 3, 2025 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | May 30, 2025 |
| K242376 | Next Generation Access Platform | December 30, 2024 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | September 27, 2024 |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | July 2, 2024 |
| K234074 | Next Generation Access Catheter | July 2, 2024 |
| K230609 | NG Delivery Catheter | September 13, 2023 |
| K223386 | Optima Coil System | December 6, 2022 |
| K213435 | MAGIC Flow-Dependent Microcatheter | July 19, 2022 |
| K202366 | MAGIC Infusion Catheter | January 29, 2021 |
| K200030 | Optima Coil System | February 1, 2020 |
| K183045 | Eclipse 2L | April 30, 2019 |
| K182918 | Ballast 088 Long Sheath | March 21, 2019 |
| K182337 | HYBRID Guidewire | October 4, 2018 |