510(k) K210681
K210681 is an FDA 510(k) premarket notification submitted by Ensite Vascular for the device "SiteSeal SV". The FDA issued a decision of Substantially Equivalent on April 6, 2021. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Ensite Vascular has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2021
- Date Received
- March 8, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type