510(k) K243638

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

K243638 is an FDA 510(k) premarket notification submitted by Microvention for the device "MV Flow Aspiration Pump (MVFLOWPMP01)". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Microvention has at least 10 other 510(k) clearances on record.

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