Optima Coil System
- Primary DI
- 00810068568752
- Brand
- Optima Coil System
- Company
- BALT USA LLC
- Model
- OPTI0635BLK
- Catalog number
- N/A
- Device description
- 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.
- Published
- 2024-10-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| HCG | Device, Neurovascular Embolization |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | Neurology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K223386 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810068568752 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store at a controlled room temperature in a dry place. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 1-949-788-1443 | customerservice@balt-usa.com |
Regulatory Flags
- DUNS number
- 945543689
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00840303714255 | Optima Coil System (OptiOne Coil System) | OPTIONE3S | N/A | 2026-01-28 |
| 00840303714262 | Optima Coil System (OptiOne Coil System) | OPTIONE3M | N/A | 2026-01-28 |
| 00840303714279 | Optima Coil System (OptiOne Coil System) | OPTIONE3L | N/A | 2026-01-28 |
| 00840303714286 | Optima Coil System (OptiOne Coil System) | OPTIONE35S | N/A | 2026-01-28 |
| 00840303714293 | Optima Coil System (OptiOne Coil System) | OPTIONE35M | N/A | 2026-01-28 |
| 00840303714309 | Optima Coil System (OptiOne Coil System) | OPTIONE35L | N/A | 2026-01-28 |
| 00840303714316 | Optima Coil System (OptiOne Coil System) | OPTIONE4S | N/A | 2026-01-28 |
| 00840303714323 | Optima Coil System (OptiOne Coil System) | OPTIONE4M | N/A | 2026-01-28 |
| 00840303714330 | Optima Coil System (OptiOne Coil System) | OPTIONE4L | N/A | 2026-01-28 |
| 00840303714347 | Optima Coil System (OptiOne Coil System) | OPTIONE45S | N/A | 2026-01-28 |
| 00840303714354 | Optima Coil System (OptiOne Coil System) | OPTIONE45M | N/A | 2026-01-28 |
| 00840303714361 | Optima Coil System (OptiOne Coil System) | OPTIONE45L | N/A | 2026-01-28 |
| 00840303714378 | Optima Coil System (OptiOne Coil System) | OPTIONE5S | N/A | 2026-01-28 |
| 00840303714385 | Optima Coil System (OptiOne Coil System) | OPTIONE5M | N/A | 2026-01-28 |
| 00840303714392 | Optima Coil System (OptiOne Coil System) | OPTIONE5L | N/A | 2026-01-28 |
| 00840303714408 | Optima Coil System (OptiOne Coil System) | OPTIONE5XL | N/A | 2026-01-28 |
| 00840303714415 | Optima Coil System (OptiOne Coil System) | OPTIONE55S | N/A | 2026-01-28 |
| 00840303714422 | Optima Coil System (OptiOne Coil System) | OPTIONE55M | N/A | 2026-01-28 |
| 00840303714439 | Optima Coil System (OptiOne Coil System) | OPTIONE55L | N/A | 2026-01-28 |
| 00840303714446 | Optima Coil System (OptiOne Coil System) | OPTIONE55XL | N/A | 2026-01-28 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00840303714262 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714279 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714286 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714293 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714309 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714316 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714323 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714330 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714347 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714354 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714361 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714378 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714385 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714392 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714408 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714415 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714422 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714439 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714446 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714453 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714460 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714477 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00840303714484 | Optima Coil System (OptiOne Coil System) | BALT USA LLC | HCG | 2026-01-28 |
| 00810169722039 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |
| 00810169722046 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |
| 00810169722053 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |
| 00810169722060 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |
| 00810169722077 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |
| 00810169722084 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |
| 00810169722091 | swiftMATCH Coil, Extra Soft | PENUMBRA, INC. | HCG | 2026-01-26 |