510(k) K221518

NP Medical nCompass Extension Set with Stabilizing Base by Np Medical — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2022
Date Received
May 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type