510(k) K190318
K190318 is an FDA 510(k) premarket notification submitted by Vasoinnovations, Inc. for the device "VASOBand Vascular Compression Device". The FDA issued a decision of Substantially Equivalent on March 14, 2019. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Vasoinnovations, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2019
- Date Received
- February 13, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type