Cleared Traditional

K843444 - ARGYLE SILICONE LEFT VENTRICULAR AND

K843444 is the FDA 510(k) clearance for ARGYLE SILICONE LEFT VENTRICULAR AND by Sherwood Medical Co.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K843444 · Sherwood Medical Co. · Cardiovascular device
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Oct 1984
Decision
43d
Days
Class 2
Risk

K843444 is an FDA 510(k) clearance for the ARGYLE SILICONE LEFT VENTRICULAR AND. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 43 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 K843444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date October 18, 1984
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 K843444.
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI
K844138 · Shiley, Inc. · Dec 1984
STOCKERT-SHILEY INTRACARDIAC SUCKERS
K844139 · Shiley, Inc. · Dec 1984
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH
K844140 · Shiley, Inc. · Dec 1984
SHILEY CORONARY CARDIOPLEGIA ADAPTOR
K843542 · Shiley, Inc. · Oct 1984
ARGYLE CUSTOM TUBING PACK
K842889 · Sherwood Medical Co. · Aug 1984
VENOUS CANNULA W/BENT, TIP WIRE
K842375 · Dlp, Inc. · Aug 1984