510(k) K240261
Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) by
Merit Medical Systems, Inc.
— Product Code KRD
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2024
- Date Received
- January 31, 2024
- 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