Cleared Traditional

BECTON DICKINSON BLUNT PLASTIC CANNULA

K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Jun 1998
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K974363 is an FDA 510(k) clearance for the BECTON DICKINSON BLUNT PLASTIC CANNULA, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 3, 1998, 196 days after receiving the submission on November 19, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K974363 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1997
Decision Date June 03, 1998
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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