Cleared Traditional

K853283 - VACCESS TM 4006

K853283 is an FDA 510(k) clearance for VACCESS TM 4006, manufactured by Vas-Cath of Canada , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K853283 · Vas-Cath of Canada , Ltd. · Gastroenterology & Urology device
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Aug 1985
Decision
17d
Days
Class 2
Risk

K853283 is an FDA 510(k) clearance for the VACCESS TM 4006. 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 August 22, 1985 after a review of 17 days - a notably fast clearance cycle.

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: 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 Vas-Cath of Canada , Ltd. devices

FDA 510(k) Submission Details - K853283

510(k) Number K853283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date August 22, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 131d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K853283.
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K863697 · Shiley, Inc. · Oct 1986
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
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
K844336 · Vas-Cath of Canada , Ltd. · Mar 1985
VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
K844433 · Vas-Cath of Canada , Ltd. · Mar 1985