510(k) K171946
K171946 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "Gel-Bead". The FDA issued a decision of Substantially Equivalent on Oct 25, 2017. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Vascular Solutions, Inc. has 114 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2017
- Date Received
- Jun 29, 2017
- 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
- 510(k)