Cleared Traditional

K895506 - FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER

K895506 is an FDA 510(k) clearance for FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER, manufactured by Vas-Cath, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K895506 · Vas-Cath, Inc. · Gastroenterology & Urology device
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Feb 1990
Decision
150d
Days
Class 2
Risk

K895506 is an FDA 510(k) clearance for the FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on February 9, 1990 after a review of 150 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 Vas-Cath, Inc. devices

FDA 510(k) Submission Details - K895506

510(k) Number K895506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date February 09, 1990
Days to Decision 150 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
20d slower than avg
Panel avg: 130d · This submission: 150d
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 K895506.
DUALYSE-CATH - CODES #1132.212, 1132.112
K896568 · Vygon Corp. · 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
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
K895417 · Arrow Intl., Inc. · Jan 1990
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K893439 · Medical Components, Inc. · Jun 1989
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
K891753 · Akcess Medical Products, Inc. · Jun 1989