Optima Coil System (Optima Packing Coil System)
Balt USA, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014162263 | 3014162263 | BALT USA, LLC | 1 | N | 2026-01-01 | 29 Parker Irvine CA US 92618 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00840303714255 | Optima Coil System (OptiOne Coil System) - The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303714262 | Optima Coil System (OptiOne Coil System) - The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded. | 1-949-788-1443 | customerservice@balt-usa.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216197 | 2018930622 | P250009 | SQUID Liquid Embolic Agent (LEA) | SGU | 2026-01-30 |
| 216197 | 1062812917 | K254221 | Optima Coil System (OptiOne Coil System) | HCG | 2026-01-27 |
| 216197 | 1271778258 | K252700 | Optima Coil System (Optima Packing Coil System) | HCG | 2025-09-26 |
| 216197 | 1712087144 | K252569 | Carrier XL Delivery Catheter | QJP | 2025-10-22 |
| 216197 | 1577251605 | K251383 | Prestige Coil System (Prestige Packing Line Extension) | KRD | 2025-05-30 |
| 216197 | 1403698946 | K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2025-06-03 |
| 216197 | 1365608483 | K242582 | Optima Coil System (OptiBlock Line Extension) | HCG | 2024-09-27 |
| 216197 | 2034973077 | K242376 | Next Generation Access Platform | QJP | 2024-12-30 |
| 216197 | 1308494738 | K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2024-07-02 |
| 216197 | 1538139412 | K234074 | Next Generation Access Catheter | QJP | 2024-07-02 |
| 216197 | 1789028884 | K230609 | NG Delivery Catheter | QJP | 2023-09-13 |
| 216197 | 1736614425 | K223386 | Optima Coil System | HCG | 2022-12-06 |
| 216197 | 1280004328 | K220699 | Prestige Coil System | KRD | 2022-04-08 |
| 216197 | 1520239185 | K213435 | MAGIC Flow-Dependent Microcatheter | KRA | 2022-07-19 |
| 216197 | 1314405223 | K200030 | Optima Coil System | HCG | 2020-02-01 |
| 216197 | 1261677349 | K183045 | Eclipse 2L | MJN | 2019-04-30 |
| 216197 | 1902861340 | K182918 | Ballast 088 Long Sheath | DQY | 2019-03-21 |
| 216197 | 1967583113 | K182337 | HYBRID Guidewire | MOF | 2018-10-04 |
| 216197 | 1729398654 | K172390 | Optima Coil System | HCG | 2018-02-18 |
| 216197 | 1623676155 | K123338 | BARRICADE EMBOLIZATION COIL SYSTEM | HCG | 2013-03-28 |
| 216197 | 2007002642 | K023351 | MAGIC INFUSION CATHETER | KRA | 2003-02-20 |
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA LLC
Balt USA, LLC
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2026-01-28
2025-08-19
2025-08-19
2025-08-19
2025-08-18
2025-08-18
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09
2025-06-09