Balt USA, LLC
Medical device manufacturer in Irvine, CA.
19510(k) clearances
1PMA approvals
8recalls
Device types
- QJP Catheter, Percutaneous, Neurovasculature 6
- HCG Device, Neurovascular Embolization 5
- KRA Catheter, Continuous Flush 2
- NRY Catheter, Thrombus Retriever 2
- MOF Guide, Wire, Catheter, Neurovasculature 1
- DQY Catheter, Percutaneous 1
- MJN Catheter, Intravascular Occluding, Temporary 1
- KRD Device, Vascular, For Promoting Embolization 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260199 | SLIM MicrocatheterQJP · Traditional | 07/13/2026SE |
| K254223 | Next Generation 088 CatheterQJP · Traditional | 04/16/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | 01/27/2026SE |
| K252569 | Carrier XL Delivery CatheterQJP · Special | 10/22/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | 09/26/2025SE |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 06/03/2025SE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension)KRD · Special | 05/30/2025SE |
| K242376 | Next Generation Access PlatformQJP · Traditional | 12/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | 09/27/2024SE |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 07/02/2024SE |
| K234074 | Next Generation Access CatheterQJP · Traditional | 07/02/2024SE |
| K230609 | NG Delivery CatheterQJP · Traditional | 09/13/2023SE |
| K223386 | Optima Coil SystemHCG · Special | 12/06/2022SE |
| K213435 | MAGIC Flow-Dependent MicrocatheterKRA · Traditional | 07/19/2022SE |
| K202366 | MAGIC Infusion CatheterKRA · Traditional | 01/29/2021SE |
| K200030 | Optima Coil SystemHCG · Special | 02/01/2020SE |
| K183045 | Eclipse 2LMJN · Traditional | 04/30/2019SE |
| K182918 | Ballast 088 Long SheathDQY · Traditional | 03/21/2019SE |
| K182337 | HYBRID GuidewireMOF · Traditional | 10/04/2018SE |
PMA approvals
- P250009 SQUID Liquid Embolic Agent (LEA) · 01/30/2026 · 1 supplement
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0188-2026 Class I | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog…Due to an identified manufacturing defect involving coating material lifting within the catheter's distal… | 09/25/2025Open, Classified |
| Z-1989-2025 Class II | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT…Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker… | 05/08/2025Open, Classified |
| Z-1988-2025 Class II | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK…Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker… | 05/08/2025Open, Classified |
| Z-1042-2024 Class II | The Prestige Coil System is a product family of embolic coils with associated delivery…Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube.… | 01/03/2024Open, Classified |
| Z-1041-2024 Class II | Neurovascular embolization device. The Optima Coil System is a series specialized coils…Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube.… | 01/03/2024Open, Classified |
| Z-0103-2023 Class II | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in…Product pouch label does not match up with carton label | 09/07/2022Open, Classified |
| Z-1680-2022 Class II | Optima Coil System Model OPTI0520CSF10. For endovascular embolization.Products were released to customers prior to the approval and release of a test report authorizing the use… | 07/26/2022Open, Classified |
| Z-0660-2022 Class II | The Optima Coil System consists of an implantable embolization coil comprised of a…Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to… | 01/04/2022Open, Classified |