SQUID Liquid Embolic Agent (LEA)
FDA premarket approval P250009 · decided 2026-01-30
Approval details
- PMA number
- P250009
- Trade name
- SQUID Liquid Embolic Agent (LEA)
- Generic name
- Neurovascular Liquid Embolic Agent
- Applicant
- Balt USA, LLC
- Date received
- 2025-03-21
- Decision date
- 2026-01-30
- Days to decision
- 315 days
- Decision code
- APPR
- Product code
- SGU
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- The SQUID Liquid Embolic Agent is indicated for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness in whom an intervention is deemed necessary as determined by a neurosurgeon.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SLIM Microcatheter (K260199) | Balt USA, LLC | 2026-07-13 |
| Next Generation 088 Catheter (K254223) | Balt USA, LLC | 2026-04-16 |
| Optima Coil System (OptiOne Coil System) (K254221) | Balt USA, LLC | 2026-01-27 |
| Carrier XL Delivery Catheter (K252569) | Balt USA, LLC | 2025-10-22 |
| Optima Coil System (Optima Packing Coil System) (K252700) | Balt USA, LLC | 2025-09-26 |
| Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948) | Balt USA, LLC | 2025-06-03 |
| Prestige Coil System (Prestige Packing Line Extension) (K251383) | Balt USA, LLC | 2025-05-30 |
| Next Generation Access Platform (K242376) | Balt USA, LLC | 2024-12-30 |