Cleared Traditional

K831591 - AORTIC ROOT CANNULA W/INTEGRAL PRESS

K831591 is the FDA 510(k) clearance for AORTIC ROOT CANNULA W/INTEGRAL PRESS by Dlp, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K831591 · Dlp, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K831591.
INFANT VENT CATHETER 12001 W/SIDE VENT
K834039 · Dlp, Inc. · Jan 1984
UNIVERSAL CORONARY CANNULA
K831330 · Possis Medical, Inc. · Aug 1983
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · Sherwood Medical Co. · Jun 1983
ARGYLE CAROTID ARTERY LOOP SHUNT
K822317 · Sherwood Medical Co. · Aug 1982
SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES
K822210 · 3M Health Care, Sarns · Aug 1982
KONTRON LITWAK-KOFFSKY OBTURATED CANNU
K821316 · Kontron Instruments, Inc. · Aug 1982