510(k) K221518

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

K221518 is an FDA 510(k) premarket notification submitted by Np Medical for the device "NP Medical nCompass Extension Set with Stabilizing Base". The FDA issued a decision of Substantially Equivalent on November 3, 2022. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Np Medical has at least 5 other 510(k) clearances on record.

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