510(k) K230706
K230706 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "EMBOLD Soft Detachable Coil System". The FDA issued a decision of Substantially Equivalent on Jun 27, 2023. 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 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 2023
- Date Received
- Mar 14, 2023
- Clearance Type
- Traditional
- 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
- 510(k)