Cleared Traditional

K896568 - DUALYSE-CATH - CODES #1132.212

K896568 is an FDA 510(k) clearance for DUALYSE-CATH - CODES #1132.212, manufactured by Vygon Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K896568 · Vygon Corp. · Gastroenterology & Urology device
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May 1990
Decision
170d
Days
Class 2
Risk

K896568 is an FDA 510(k) clearance for the DUALYSE-CATH - CODES #1132.212, 1132.112. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Vygon Corp. (New York, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 170 days - an extended review 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: 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 Vygon Corp. devices

FDA 510(k) Submission Details - K896568

510(k) Number K896568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1989
Decision Date May 09, 1990
Days to Decision 170 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
40d slower than avg
Panel avg: 130d · This submission: 170d
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 54
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K896568.
SINGLE LUMEN CATHETERS, MODIFICATION
K904140 · Akcess Medical Products, Inc. · Nov 1990
DURACATH
K901133 · Impra, Inc. · Jun 1990
SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000
K901061 · Akcess Medical Products, Inc. · May 1990
MODIFIED PERM-CATH
K900835 · Quinton, Inc. · May 1990
DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S
K900803 · Akcess Medical Products, Inc. · Apr 1990
FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER
K895506 · Vas-Cath, Inc. · Feb 1990