510(k) K153502
K153502 is an FDA 510(k) premarket notification submitted by Vascular Insights, LLC for the device "ClariVein IC". The FDA issued a decision of Substantially Equivalent on January 6, 2016. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Vascular Insights, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2016
- Date Received
- December 7, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type