Cleared Traditional

BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube

K230493 · Becton, Dickinson and Company · Hematology
Nov 2023
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K230493 is an FDA 510(k) clearance for the BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube, a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on November 27, 2023, 277 days after receiving the submission on February 23, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K230493 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2023
Decision Date November 27, 2023
Days to Decision 277 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIM — Tubes, Vacuum Sample, With Anticoagulant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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