510(k) clearance

Gravity Blood Sets with 200µm Filter

FDA 510(k) source

510(k) number

K260261

Applicant

B.Braun Medical, Inc.

Decision date

Oct 22, 2026

Date received

Jan 28, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FPA

Device type

Set, Administration, Intravascular

Device class

Class II

Regulation

21 CFR 880.5440

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

Bethlehem, PA, US