510(k) K210114
K210114 is an FDA 510(k) premarket notification submitted by Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular for the device "Rebar Micro Catheter". The FDA issued a decision of Substantially Equivalent on Feb 16, 2021. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 2021
- Date Received
- Jan 19, 2021
- 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
- 510(k)