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Data / Medical devices / United States / Balt Usa, LLC

Balt Usa, LLC: FDA-registered device maker in Irvine, CA, United States, 22 510(k) clearances and 1 PMA approval

Balt Usa, LLC is registered with the FDA (registration 3014162263) in Irvine, CA, United States. It lists 10 device types. The FDA files 22 510(k) clearances and 1 PMA approval under its listings, the newest dated July 13, 2026. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Balt Usa, LLC
FDA registration number
3014162263
Address
29 Parker, Irvine, CA, United States, 92618
Owner or operator
Balt USA, LLC (10041614)
Roles
Complaint file establishment, Manufacturer
First device listed
April 3, 2017
Registered through
2026
Brand names listed
Allure Coil System, Allure Coil System Detachment Controller, Ballast 088 Long Sheath, Barricade Coil System, Carrier Delivery Catheter, Carrier XL Delivery Catheter, ECLIPSE 2L, HYBRID Guidewire and more

Devices it lists

DeviceProduct codeClassRoleSource
Catheter, Continuous FlushKRA2Complaint file establishment, Manufactureraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Complaint file establishment, Manufactureraccessdata.fda.gov
Catheter, Percutaneous, NeurovasculatureQJP2Complaint file establishment, Manufactureraccessdata.fda.gov
Catheter, Thrombus RetrieverNRY2Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Neurovascular EmbolizationHCG2Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Complaint file establishment, Manufactureraccessdata.fda.gov
Guide, Wire, Catheter, NeurovasculatureMOF2Manufactureraccessdata.fda.gov
Neurovascular Liquid Embolic AgentSGU3Complaint file establishment, Manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 13, 2026K260199SLIM MicrocatheterQJPSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
April 16, 2026K254223Next Generation 088 CatheterQJPSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
January 27, 2026K254221Optima Coil System (OptiOne Coil System)HCGSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
October 22, 2025K252569Carrier XL Delivery CatheterQJPSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
September 26, 2025K252700Optima Coil System (Optima Packing Coil System)HCGSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
June 3, 2025K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRYSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
May 30, 2025K251383Prestige Coil System (Prestige Packing Line Extension)KRDSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
December 30, 2024K242376Next Generation Access PlatformQJPSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
September 27, 2024K242582Optima Coil System (OptiBlock Line Extension)HCGSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
July 2, 2024K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRYSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
July 2, 2024K234074Next Generation Access CatheterQJPSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
September 13, 2023K230609NG Delivery CatheterQJPSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
December 6, 2022K223386Optima Coil SystemHCGSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
July 19, 2022K213435MAGIC Flow-Dependent MicrocatheterKRASubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
April 8, 2022K220699Prestige Coil SystemKRDSubstantially EquivalentBait USA, LLCaccessdata.fda.gov
February 1, 2020K200030Optima Coil SystemHCGSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
April 30, 2019K183045Eclipse 2LMJNSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
March 21, 2019K182918Ballast 088 Long SheathDQYSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
October 4, 2018K182337HYBRID GuidewireMOFSubstantially EquivalentBalt USA, LLCaccessdata.fda.gov
February 18, 2018K172390Optima Coil SystemHCGSubstantially EquivalentBlockade Medical, LLC (D.B.A. Balt Usa)accessdata.fda.gov
March 28, 2013K123338BARRICADE EMBOLIZATION COIL SYSTEMHCGSubstantially EquivalentBlockade Medicalaccessdata.fda.gov
February 20, 2003K023351MAGIC INFUSION CATHETERKRASubstantially EquivalentAdvanced Interventional Technologies, LLCaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
January 30, 2026P250009SQUID Liquid Embolic Agent (LEA)SGU2October 16, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 25, 202597661Class IOngoingBrand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is desDue to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.accessdata.fda.gov
May 8, 202596787Class IIOngoingOptima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.accessdata.fda.gov
January 3, 202493751Class IIOngoingNeurovascular 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 other vascular anomalDiscoloration 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 discolorataccessdata.fda.gov
September 7, 202290870Class IIOngoingOptima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.Product pouch label does not match up with carton labelaccessdata.fda.gov
July 26, 202290724Class IIOngoingOptima 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 of an existing material from an alternate supplier.accessdata.fda.gov
January 4, 202289338Class IIOngoingThe 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 radiopaque distal poDue 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 saiaccessdata.fda.gov

Compare with other makers

Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.