Cleared Traditional

RESUBMITTED MULTIORGAN PERFUSION CANNULA

K902394 · Fresenius USA, Inc. · Cardiovascular

Sep 1990

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K902394 is an FDA 510(k) clearance for the RESUBMITTED MULTIORGAN PERFUSION CANNULA, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Fresenius USA, Inc. (New Brunswick, US). The FDA issued a Cleared decision on September 27, 1990, 120 days after receiving the submission on May 30, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K902394 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1990
Decision Date	September 27, 1990
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210