K253376
- 510(k) number
- K253376
- Device name
- OBSIDIO Conformable Embolic (M0013972101010)
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-10-30
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253376.pdf
Official FDA record: K253376
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.