510(k) K190351
K190351 is an FDA 510(k) premarket notification submitted by Ensite Vascular for the device "Site Seal SV". The FDA issued a decision of Substantially Equivalent on Jul 2, 2019. 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
- Jul 2, 2019
- Date Received
- Feb 14, 2019
- Clearance Type
- Traditional
- 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