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BALT 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
LinkedIn: —
Facebook: —
Email: [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 8 of 23

Device	Model / Reference	Registries	Class	Status
Barricade Coil System	900066	FDA UDI	Class II	Active
Barricade Coil System	900106	FDA UDI	Class II	Active
Optima Coil System	OPTI0508HSF10	FDA UDI	Class II	Active
Prestige Coil System	PRES0404CPKPL	FDA UDI	Class II	Active
Barricade Coil System	900082	FDA UDI	Class II	Active
Optima Coil System	PRES0724CPK10	FDA UDI	Class II	Active
Ballast 088 Long Sheath	BALLAST90SD	FDA UDI	Class II	Active
Optima Coil System	OPTI0156BLK	FDA UDI	Class II	Active
Optima Coil System	OPTI0408HSS10	FDA UDI	Class II	Active
Prestige Coil System	PRES2465CPKPLT	FDA UDI	Class II	Active
Optima Coil System	OPTI0620HSF10	FDA UDI	Class II	Active
Prestige Coil System	PRES2525CXPPL	FDA UDI	Class II	Active
Ballast 088 Long Sheath	BALLAST80	FDA UDI	Class II	Active
Optima Coil System	OPTI0104CSS10	FDA UDI	Class II	Active
Optima Coil System	PRES0204CXP10	FDA UDI	Class II	Active
Prestige Coil System	PRES0506HPK10	FDA UDI	Class II	Active
Barricade Coil System	900063	FDA UDI	Class II	Active
Prestige Coil System	PRES0151HXP10	FDA UDI	Class II	Active
Optima Coil System	OPTI0510HSS10	FDA UDI	Class II	Active
Optima Coil System	PRES0724COM18	FDA UDI	Class II	Active
Prestige Coil System	PRES0615CPKPLT	FDA UDI	Class II	Active
Prestige Coil System	PRES0306CRG10	FDA UDI	Class II	Active
Prestige Coil System	PRES0103HXPPL	FDA UDI	Class II	Active
Prestige Coil System	PRES0358CXP10	FDA UDI	Class II	Active
Barricade Coil System	900135	FDA UDI	Class II	Active
Optima Coil System	OPTI0206CSS10	FDA UDI	Class II	Active
Prestige Coil System	PRES0255HXPPL	FDA UDI	Class II	Active
Optima Coil System	OPTI0510CSS10	FDA UDI	Class II	Active
Prestige Coil System	PRES0255HXPPL	FDA UDI	Class II	Active
Optima Coil System	OPTI1550COM18	FDA UDI	Class II	Active
Optima Coil System	PRES0930CRG10	FDA UDI	Class II	Active
Optima Coil System	OPTI0724CSF10	FDA UDI	Class II	Active
Optima Coil System	OPTI0620COM18	FDA UDI	Class II	Active
Prestige Coil System	PRES0307CXPPL	FDA UDI	Class II	Active
Barricade Coil System	900131	FDA UDI	Class II	Active
Barricade Coil System	900040	FDA UDI	Class II	Active
Barricade Coil System	900080	FDA UDI	Class II	Active
Optima Coil System	OPTI2535HSSMX	FDA UDI	Class II	Active
Optima Coil System	OPTI0930HSFMX	FDA UDI	Class II	Active
Prestige Coil System	PRES0306CRG10	FDA UDI	Class II	Active
Prestige Coil System	PRES0820CPKPL	FDA UDI	Class II	Active
Prestige Coil System	PRES0203HXP10	FDA UDI	Class II	Active
Prestige Coil System	PRES0304HPK10	FDA UDI	Class II	Active
Optima Coil System	OPTI0308CST10	FDA UDI	Class II	Active
MEGA Ballast Distal Access Platform	MEGABT09190	FDA UDI	Class II	Active
Optima Coil System	OPTI0517CST10	FDA UDI	Class II	Active
Optima Coil System	OPTI0315HSF10	FDA UDI	Class II	Active
Prestige Coil System	PRES0153HXPPL	FDA UDI	Class II	Active
Optima Coil System	OPTI0253CSS10	FDA UDI	Class II	Active
Barricade Coil System	900093	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.