Cleared Traditional

ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER

K984059 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital

Apr 1999

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K984059 is an FDA 510(k) clearance for the ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 9, 1999, 147 days after receiving the submission on November 13, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K984059 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1998
Decision Date	April 09, 1999
Days to Decision	147 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