Cleared Traditional

K881743 - VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS ...

K881743 is an FDA 510(k) clearance for VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS ..., 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 62-day FDA review.

K881743 · Vas-Cath, Inc. · Gastroenterology & Urology device
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Jun 1988
Decision
62d
Days
Class 2
Risk

K881743 is an FDA 510(k) clearance for the VAS-CATH FLEXXICON 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 June 23, 1988 after a review of 62 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, Inc. devices

FDA 510(k) Submission Details - K881743

510(k) Number K881743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date June 23, 1988
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 K881743.
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · Impra, Inc. · Dec 1988
VAS-CATH CATHETER REPAIR KIT
K883768 · Vas-Cath, Inc. · Nov 1988
MEDSURG ACUTE DIALYSIS TRAY
K880778 · Medsurg Industries, Inc. · Jul 1988
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
K881290 · Shiley, Inc. · Apr 1988
PERMCATH INSERTION TRAY
K874633 · Quinton, Inc. · Feb 1988
ADULT PERM-CATH 40CM.
K871749 · Quinton, Inc. · Jun 1987