Cleared Traditional

K952861 - ANGIOCATH & INSYTE AUTOGUARD CATHETERS
(FDA 510(k) Clearance)

K952861 · Becton Dickinson Vascular Access, Inc. · General Hospital

Jul 1995

Decision

39d

Days

Class 2

Risk

K952861 is an FDA 510(k) clearance for the ANGIOCATH & INSYTE AUTOGUARD CATHETERS. This device is classified as 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, 39 days after receiving the submission on June 22, 1995.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K952861 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 1995
Decision Date	July 31, 1995
Days to Decision	39 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