Cleared Traditional

ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER

K952757 · Becton Dickinson Vascular Access, Inc. · General Hospital

Jul 1995

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K952757 is an FDA 510(k) clearance for the ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on July 31, 1995, 45 days after receiving the submission on June 16, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K952757 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 1995
Decision Date	July 31, 1995
Days to Decision	45 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200