Cleared Traditional

K844433 - VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CA...

K844433 is the FDA 510(k) clearance for VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CA... by Vas-Cath of Canada , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code LFJ) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K844433 · Vas-Cath of Canada , Ltd. · Gastroenterology & Urology device
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Mar 1985
Decision
117d
Days
Class 2
Risk

K844433 is an FDA 510(k) clearance for the VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Vas-Cath of Canada , Ltd. (Ontario, L5a 3v3, CA). The FDA issued a Cleared decision on March 13, 1985 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vas-Cath of Canada , Ltd. devices

Submission Details

510(k) Number K844433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date March 13, 1985
Days to Decision 117 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 130d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LFJ Catheter, Subclavian

All 23
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K844433.
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K861174 · Shiley, Inc. · Apr 1986
HURWITZ DIALYSIS CATHETER
K860094 · Gish Biomedical, Inc. · Apr 1986
SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL
K852070 · Shiley, Inc. · Jun 1985
SINGLE LUMEN SUBCLAVIAN CANNULA
K840197 · Shiley, Inc. · Apr 1984
DUAL LUMEN SUBCLAVIAN CANNULA
K833848 · Shiley, Inc. · Dec 1983
DOUBLE LUMEN SUBCLAVIAN CATHETER
K823135 · Abbott Laboratories · Mar 1983