510(k) K253070

Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) by Medline Industries, LP — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2025
Date Received
September 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type