510(k) K253376
K253376 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "OBSIDIO Conformable Embolic (M0013972101010)". The FDA issued a decision of Substantially Equivalent on October 30, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2025
- Date Received
- September 30, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vascular, For Promoting Embolization
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- CV
- Submission Type