510(k) K223139

Wallaby 017 Micro Catheter by Wallaby Medical — Product Code KRA

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