510(k) K243638

MV Flow Aspiration Pump (MVFLOWPMP01) by Microvention — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2025
Date Received
November 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type