Optima Coil System (OptiOne Coil System)
FDA 510(k) K254221 · Balt USA, LLC
510(k) numberK254221
Submission
- Device name
- Optima Coil System (OptiOne Coil System)
- Applicant
- Balt USA, LLC
Irvine, CA, US - Received
- December 29, 2025
- Decision date
- January 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | Cerenovus, Inc. | 08/14/2026SE |
| K261772 | Target Xtra Detachable CoilHCG · Special | Stryker Neurovscular | 06/24/2026SE |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | Stryker Neurovascular | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | Stryker Neurovascular | 10/17/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | Balt USA, LLC | 09/26/2025SE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
| K232955 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 01/10/2024SE |
More from MicroPort NeuroTech (Shanghai) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260199 | SLIM MicrocatheterQJP · Traditional | 07/13/2026SE |
| K254223 | Next Generation 088 CatheterQJP · Traditional | 04/16/2026SE |
| K252569 | Carrier XL Delivery CatheterQJP · Special | 10/22/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | 09/26/2025SE |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 06/03/2025SE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension)KRD · Special | 05/30/2025SE |
| K242376 | Next Generation Access PlatformQJP · Traditional | 12/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | 09/27/2024SE |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 07/02/2024SE |
| K234074 | Next Generation Access CatheterQJP · Traditional | 07/02/2024SE |
Questions and answers
When was Optima Coil System (OptiOne Coil System) cleared by the FDA?
Optima Coil System (OptiOne Coil System) (K254221) received a 510(k) decision of Substantially Equivalent on January 27, 2026, 29 days after the submission was received.
What is the product code of K254221?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.