510(k) K252700
K252700 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "Optima Coil System (Optima Packing Coil System)". The FDA issued a decision of Substantially Equivalent on September 26, 2025. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Balt USA, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2025
- Date Received
- August 27, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type