Cleared Traditional

K921845 - INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT
(FDA 510(k) Clearance)

K921845 · Becton Dickinson Vascular Access, Inc. · Cardiovascular

Nov 1992

Decision

207d

Days

Class 2

Risk

K921845 is an FDA 510(k) clearance for the INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT. This device is classified as a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO).

Submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on November 10, 1992, 207 days after receiving the submission on April 17, 1992.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K921845 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 1992
Decision Date	November 10, 1992
Days to Decision	207 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF