K240873
- 510(k) number
- K240873
- Device name
- TEMBO Embolic System
- Applicant
- Instylla, Inc. MA · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2024-12-16
- Date received
- 2024-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K240873.pdf
Official FDA record: K240873
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.