510(k) K223139
K223139 is an FDA 510(k) premarket notification submitted by Wallaby Medical for the device "Wallaby 017 Micro Catheter". The FDA issued a decision of Substantially Equivalent on April 25, 2023. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Wallaby Medical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2023
- Date Received
- October 4, 2022
- 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