Company ยท US
Balt USA, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (3 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HCG | Device, Neurovascular Embolization | 10 |
| QJP | Catheter, Percutaneous, Neurovasculature | 6 |
| KRD | Device, Vascular, For Promoting Embolization | 3 |
| DQY | Catheter, Percutaneous | 2 |
| KRA | Catheter, Continuous Flush | 2 |
| NRY | Catheter, Thrombus Retriever | 2 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 2026 | K260199 | SLIM Microcatheter Balt USA, LLC | QJP |
| Apr 16, 2026 | K254223 | Next Generation 088 Catheter Balt USA, LLC | QJP |
| Jan 27, 2026 | K254221 | Optima Coil System (OptiOne Coil System) Balt USA, LLC | HCG |
| Oct 22, 2025 | K252569 | Carrier XL Delivery Catheter Balt USA, LLC | QJP |
| Sep 26, 2025 | K252700 | Optima Coil System (Optima Packing Coil System) Balt USA, LLC | HCG |
| Jun 3, 2025 | K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set Balt USA, LLC | NRY |
| May 30, 2025 | K251383 | Prestige Coil System (Prestige Packing Line Extension) Balt USA, LLC | KRD |
| Dec 30, 2024 | K242376 | Next Generation Access Platform Balt USA, LLC | QJP |
| Sep 27, 2024 | K242582 | Optima Coil System (OptiBlock Line Extension) Balt USA, LLC | HCG |
| Jul 2, 2024 | K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set Balt USA, LLC | NRY |
| Jul 2, 2024 | K234074 | Next Generation Access Catheter Balt USA, LLC | QJP |
| Sep 13, 2023 | K230609 | NG Delivery Catheter Balt USA, LLC | QJP |
| Dec 6, 2022 | K223386 | Optima Coil System Balt USA, LLC | HCG |
| Jul 19, 2022 | K213435 | MAGIC Flow-Dependent Microcatheter Balt USA, LLC | KRA |
| Jan 29, 2021 | K202366 | MAGIC Infusion Catheter Balt USA, LLC | KRA |
| Feb 1, 2020 | K200030 | Optima Coil System Balt USA, LLC | HCG |
| Apr 30, 2019 | K183045 | Eclipse 2L Balt USA, LLC | MJN |
| Mar 21, 2019 | K182918 | Ballast 088 Long Sheath Balt USA, LLC | DQY |
| Oct 4, 2018 | K182337 | HYBRID Guidewire Balt USA, LLC | MOF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | BALT USA, LLC Brand Name: MEGA Ballast Distal Access Platform
Product Name: Mega Ballast
Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110
Software Version: N/A
Product Description: The Meg Open, Classified |
DQY | K242376 |
| Jun 18, 2025 | BALT USA, LLC Prestige Coil System REFs/UDI-DI codes:
PRES0153CXPPLT 00810068567311
PRES1045CPKPLT 00810068567663
PRES1245CPKPLT 00810068567694
PRES1445CPKPLT 00810068567724
PRES0103CXPPLT 00810068567304
PRES2512CX Open, Classified |
KRD | K220699 |
| Jun 18, 2025 | BALT USA, LLC Optima Coil System REFs/UDI-DI codes:
OPTI0156BLK 00810068568875
OPTI0158BLK 00810068568882
OPTI0103BLK 00810068568851
OPTI0258BLK 00810068568929
OPTI0212BLK 00810068568912
OPTI0206BLK 00810068568905
Open, Classified |
HCG | K172390 K200030 |
| Feb 8, 2024 | BALT USA, LLC The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral va Open, Classified |
KRD | K220699 |
| Feb 8, 2024 | BALT USA, LLC Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and o Open, Classified |
HCG | K172390 K200030 +1 |
| Oct 20, 2022 | BALT USA, LLC Optima Coil System
Model Number OPTI0208CSS10,
Model Number OPTI0308CSS10. Used in endovascular procedures. Open, Classified |
HCG | K172390 K200030 |
| Jul 26, 2022 | BALT USA, LLC Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Open, Classified |
HCG | K172390 K200030 |
| Jan 4, 2022 | BALT USA, LLC The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a Open, Classified |
HCG | K200030 |