Cleared Traditional

K942045 - INSYTE INTRODUCER CATHETER
(FDA 510(k) Clearance)

K942045 · Becton Dickinson Vascular Access, Inc. · General Hospital

Jan 1995

Decision

256d

Days

Class 2

Risk

K942045 is an FDA 510(k) clearance for the INSYTE INTRODUCER CATHETER. 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 January 9, 1995, 256 days after receiving the submission on April 28, 1994.

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

Submission Details

510(k) Number	K942045 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1994
Decision Date	January 09, 1995
Days to Decision	256 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