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Sign in to claim this brandBALT USA LLC
United States·US-MF-000008651
Last updated May 24, 2026
What BALT USA LLC makes
BALT USA LLC manufactures embolization coils for neurovascular and non-neurovascular applications, including systems like the Optima, Prestige, and Barricade. Their portfolio also includes single-use vascular guide-catheters, thrombectomy suction catheters, vascular microcatheters, and intravascular occluding balloon catheters designed for image-guided procedures. Cardiac and peripheral vascular guidewires, intended for single-use, are also part of their offerings.
All listed devices fall under FDA Class II regulation and are included in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, where these products are subject to U.S. regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does BALT USA LLC manufacture?
BALT USA LLC specializes in embolization coils for both neurovascular and non-neurovascular treatments, such as the Optima, Prestige, and Barricade systems. Their portfolio also includes single-use vascular guide-catheters, thrombectomy suction catheters, vascular microcatheters, and intravascular occluding balloon catheters designed for image-guided procedures. Additionally, they produce single-use cardiac and peripheral vascular guidewires, catering to interventional radiology and cardiology applications.
Where is BALT USA LLC based, and how does this affect its devices?
BALT USA LLC is based in the United States, meaning its devices are subject to U.S. regulatory requirements, including FDA oversight. Since all listed devices fall under FDA Class II classification, they must comply with U.S. regulations governing their design, manufacturing, and post-market surveillance, ensuring safety and performance standards are met.
Which regulatory registries list BALT USA LLC’s devices?
BALT USA LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database, which is a centralized registry for tracking medical devices authorized in the U.S. This database helps healthcare providers, regulators, and manufacturers verify device details, including classification, manufacturer information, and compliance status.
How are BALT USA LLC’s devices classified by regulatory authorities?
All of BALT USA LLC’s listed devices fall under FDA Class II classification. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as embolization coils and guide-catheters, which require validation of performance and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 29, Parker, Irvine, United States
- Website
- www.balt-usa.com
- —
- —
- [email protected]
- Phone
- 1-949-788-1443
- PRRC Contact
- David Vu
- EUDAMED SRN
- US-MF-000008651
- FDA FEI Number
- —
- DUNS Number
- 945543689
Catalogue (1119)
Page 23 of 23| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Optima Coil System | K223386 | FDA 510(k) | Class II | Active |
| Optima Coil System (OptiOne Coil System) | K254221 | FDA 510(k) | Class II | Active |
| Optima Coil System | K200030 | FDA 510(k)FDA UDI | Class II | Active |
| Next Generation Access Catheter | K234074 | FDA 510(k) | Class II | Active |
| MAGIC Infusion Catheter | K202366 | FDA 510(k) | Class II | Active |
| MAGIC Flow-Dependent Microcatheter | K213435 | FDA 510(k) | Class II | Active |
| NG Delivery Catheter | K230609 | FDA 510(k) | Class II | Active |
| Optima Coil System (Optima Packing Coil System) | K252700 | FDA 510(k) | Class II | Active |
| Eclipse 2L | K183045 | FDA 510(k) | Class II | Active |
| Optima Coil System (OptiBlock Line Extension) | K242582 | FDA 510(k) | Class II | Active |
| Prestige Coil System (Prestige Packing Line Extension) | K251383 | FDA 510(k) | Class II | Active |
| HYBRID Guidewire | K182337 | FDA 510(k) | Class II | Active |
| Carrier XL Delivery Catheter | K252569 | FDA 510(k) | Class II | Active |
| Raptor Aspiration Catheter; Balt Aspiration Tubing Set | K243948 | FDA 510(k) | Class II | Active |
| Next Generation Access Platform | K242376 | FDA 510(k) | Class II | Active |
| Next Generation 088 Catheter | K254223 | FDA 510(k) | Class II | Active |
| Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | K234083 | FDA 510(k) | Class II | Active |
| XCEL Detachment Controller | XCEL | EUDAMEDFDA UDI | Class IIa | Active |
| SQUID Liquid Embolic Agent (LEA) | P250009 | FDA PMA | Class III | Active |
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FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Balt USA LLC has eight FDA recall records initiated between January 4, 2022, and September 25, 2025, with some classified and others remaining open. The reasons cited include labeling discrepancies such as mismatched pouch and carton labels, manufacturing defects like coating material lifting in catheters and radiopaque marker non-compliance, as well as discoloration and corrosion issues linked to solder flux residue on delivery pushers. Additional recalls involved premature product release without required test reports and potential coil size mix-ups due to inadequate manufacturing line clearance.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 25, 2025 | Z-0188-2026 | — | open, classified | Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. |
| May 8, 2025 | Z-1988-2025 | — | open, classified | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| May 8, 2025 | Z-1989-2025 | — | open, classified | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| Jan 3, 2024 | Z-1042-2024 | — | open, classified | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli. |
| Jan 3, 2024 | Z-1041-2024 | — | open, classified | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli. |
| Sep 7, 2022 | Z-0103-2023 | — | open, classified | Product pouch label does not match up with carton label |
| Jul 26, 2022 | Z-1680-2022 | — | open, classified | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. |
| Jan 4, 2022 | Z-0660-2022 | — | open, classified | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm. |