Cleared Traditional

INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS

K971339 · Becton Dickinson Vascular Access, Inc. · General Hospital

Dec 1997

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K971339 is an FDA 510(k) clearance for the INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS, 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 December 24, 1997, 258 days after receiving the submission on April 10, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K971339 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1997
Decision Date	December 24, 1997
Days to Decision	258 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