Cleared Traditional

Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)

K253070 · Medline Industries, LP · Cardiovascular
Nov 2025
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K253070 is an FDA 510(k) clearance for the Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL), a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on November 20, 2025, 58 days after receiving the submission on September 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K253070 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2025
Decision Date November 20, 2025
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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