Cleared Traditional

E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS

K952053 · Becton Dickinson Vascular Access, Inc. · General Hospital
May 1995
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K952053 is an FDA 510(k) clearance for the E-Z SET, SAF-T E-Z SET, AND MINICATH 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 May 31, 1995, 30 days after receiving the submission on May 1, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K952053 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1995
Decision Date May 31, 1995
Days to Decision 30 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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