510(k) K193082
K193082 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Fountain ValveTip Infusion Catheter". The FDA issued a decision of Substantially Equivalent on Aug 7, 2020. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 7, 2020
- Date Received
- Nov 5, 2019
- Clearance Type
- Traditional
- 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)