Cleared Traditional

AORTIC ROOT CANNULA W/INTEGRAL PRESS (K831591) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831591 · Dlp, Inc. · Cardiovascular device
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Jun 1983
Decision
44d
Days
Class 2
Risk

K831591 is an FDA 510(k) clearance for the AORTIC ROOT CANNULA W/INTEGRAL PRESS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Dlp, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 44 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 Dlp, Inc. devices

Submission Details

510(k) Number K831591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1983
Decision Date June 30, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
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 103
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K831591.
ARGYLE TAPERED VASCULAR SHUNT
K840914 · Sherwood Medical Co. · Apr 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · Shiley, Inc. · Apr 1984
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · Sherwood Medical Co. · Jun 1983
ARGYLE CAROTID ARTERY LOOP SHUNT
K822317 · Sherwood Medical Co. · Aug 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · Sherwood Medical Co. · Jul 1982
SHILEY CARDIOPLEGIC SOLUTION DEL SETS
K791947 · Shiley, Inc. · Nov 1979