Cleared Traditional

K905312 - DURAFLO II HEPARIN TREATED FEMORAL CANN...

K905312 is the FDA 510(k) clearance for DURAFLO II HEPARIN TREATED FEMORAL CANN... by Baxter Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K905312 · Baxter Bentley Laboratories, Inc. · Cardiovascular device
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Jan 1991
Decision
48d
Days
Class 2
Risk

K905312 is an FDA 510(k) clearance for the DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Baxter Bentley Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K905312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date January 15, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K905312.
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
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · Fresenius USA, Inc. · Sep 1990
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · C.R. Bard, Inc. · Aug 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · Dlp, Inc. · Jul 1990