FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Optima Coil System (OptiOne Coil System)
K Number: K254221
·
Decision Jan 27, 2026
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
18
Review Days
29
Basic Information
- Device Name
- Optima Coil System (OptiOne Coil System)
- K Number
- K254221
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Balt USA, LLC
- Date Received
- December 29, 2025
- Decision Date
- January 27, 2026
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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Other Clearances by Balt USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K254223 | Next Generation 088 Catheter | Apr 16, 2026 | Substantially Equivalent |
| K252569 | Carrier XL Delivery Catheter | Oct 22, 2025 | Substantially Equivalent |
| K252700 | Optima Coil System (Optima Packing Coil System) | Sep 26, 2025 | Substantially Equivalent |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Jun 3, 2025 | Substantially Equivalent |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | May 30, 2025 | Substantially Equivalent |
| K242376 | Next Generation Access Platform | Dec 30, 2024 | Substantially Equivalent |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Sep 27, 2024 | Substantially Equivalent |
| K234074 | Next Generation Access Catheter | Jul 2, 2024 | Substantially Equivalent |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Jul 2, 2024 | Substantially Equivalent |
| K230609 | NG Delivery Catheter | Sep 13, 2023 | Substantially Equivalent |