Cleared Traditional

E-Z SET(R) AND MINICATH(R) INFUSION SETS

K950302 · Becton Dickinson Vascular Access, Inc. · General Hospital
Mar 1995
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K950302 is an FDA 510(k) clearance for the E-Z SET(R) AND MINICATH(R) INFUSION SETS, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on March 13, 1995, 47 days after receiving the submission on January 25, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K950302 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1995
Decision Date March 13, 1995
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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