510(k) K230636
K230636 is an FDA 510(k) premarket notification submitted by Merit Medical System, Inc. for the device "Maestro Microcatheter". The FDA issued a decision of Substantially Equivalent on March 30, 2023. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Merit Medical System, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2023
- Date Received
- March 7, 2023
- 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