Cleared Traditional

K831332 - ARGYLE DUAL STAGE VENOUS RETURN CATH.

K831332 is the FDA 510(k) clearance for ARGYLE DUAL STAGE VENOUS RETURN CATH. by Sherwood Medical Co.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K831332 · Sherwood Medical Co. · Cardiovascular device
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Jun 1983
Decision
66d
Days
Class 2
Risk

K831332 is an FDA 510(k) clearance for the ARGYLE DUAL STAGE VENOUS RETURN CATH.. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 66 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K831332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date June 30, 1983
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 229
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K831332.
ARTERIAL CANNULA CURVED BEVELED TIP
K840002 · Dlp, Inc. · Feb 1984
SARNS CARDIOPLEGIA CANNULA Y
K834025 · 3M Health Care, Sarns · Jan 1984
INFANT VENT CATHETER 12001 W/SIDE VENT
K834039 · Dlp, Inc. · Jan 1984
AORTIC ROOT CANNULA W/INTEGRAL PRESS
K831591 · Dlp, Inc. · 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