Cleared Traditional

BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE

K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital

Feb 2001

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K003461 is an FDA 510(k) clearance for the BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE, 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 February 1, 2001, 86 days after receiving the submission on November 7, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K003461 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2000
Decision Date	February 01, 2001
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF