FDA Registration
Active
🇺🇸 United States
BALT USA, LLC
Reg #: 3014162263
·
FEI: 3014162263
·
Expires 2026
Products
10
Proprietary Names
22
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- BALT USA, LLC
- Registration Number
- 3014162263
- FEI Number
- 3014162263
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 29 Parker
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K023351
- PMA Number
- P250009
Owner / Operator
- Firm Name
- Balt USA, LLC
- Operator Number
- 10041614
- Address
- 29 Parker
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2017-04-03 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2025-06-04 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2018-02-20 |
| Neurovascular Liquid Embolic Agent | SGU | Class 3 | Unknown | No | 2026-02-12 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2024-07-16 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-07-16 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-07-16 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2018-10-08 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2018-10-08 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2019-06-12 |
Proprietary Names
Magic Infusion Catheter
Prestige Coil System (Prestige Packing Line Extension)
Optima Coil System
XCEL Detachment Controller
Stellar Guide Catheter
Carrier XL Delivery Catheter
Barricade Coil System
Ultra Detachment Controller
Allure Coil System Detachment Controller
Allure Coil System
Prestige Coil System
Raptor Aspiration Catheter
Raptor Aspiration Catheter; Balt Aspiration Tubing Set
Optima Coil System (OptiOne Coil System)
Prestige Plus Coil System
MAGIC Flow-Dependent Microcatheter
Ballast 088 Long Sheath
Revere Hybrid Access Catheter
Carrier Delivery Catheter
HYBRID Guidewire
ECLIPSE 2L
MEGA Ballast Distal Access Platform
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198