Cleared Traditional

K902394 - RESUBMITTED MULTIORGAN PERFUSION CANNULA

K902394 is an FDA 510(k) clearance for RESUBMITTED MULTIORGAN PERFUSION CANNULA, manufactured by Fresenius USA, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K902394 · Fresenius USA, Inc. · Cardiovascular device
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Sep 1990
Decision
120d
Days
Class 2
Risk

K902394 is an FDA 510(k) clearance for the RESUBMITTED MULTIORGAN PERFUSION CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (New Brunswick, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K902394

510(k) Number K902394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date September 27, 1990
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 299
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K902394.
SARNS RETROGRADE CANNULA
K915193 · 3M Health Care, Sarns · Mar 1992
CARDIOPULMONARY BYPASS VASCULAR CATHETER
K905224 · 3M Health Care, Sarns · Feb 1991
SARNS INVENT CATHETERS
K905638 · 3M Health Care, Sarns · Feb 1991
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · C.R. Bard, Inc. · Aug 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · Dlp, Inc. · Jul 1990
RMI CARDIOPLEGIA DELIVERY KITS
K901231 · Research Medical, Inc. · Jun 1990