Cleared Traditional

K871488 - VAS-CATH PERMANENT DUAL LUMEN HEMODIALY...

K871488 is the FDA 510(k) clearance for VAS-CATH PERMANENT DUAL LUMEN HEMODIALY... 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 58-day FDA review.

K871488 · Vas-Cath of Canada , Ltd. · Gastroenterology & Urology device
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Jun 1987
Decision
58d
Days
Class 2
Risk

K871488 is an FDA 510(k) clearance for the VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH. 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 June 12, 1987 after a review of 58 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

Submission Details

510(k) Number K871488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1987
Decision Date June 12, 1987
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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 K871488.
PERMCATH INSERTION TRAY
K874633 · Quinton, Inc. · Feb 1988
ADULT PERM-CATH 40CM.
K871749 · Quinton, Inc. · Jun 1987
PERM-CATH CATHETER KIT
K871942 · Quinton, Inc. · Jun 1987
SINGLE LUMEN ACUTE CATHETER
K870328 · Quinton, Inc. · May 1987
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K863697 · Shiley, Inc. · Oct 1986
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K861174 · Shiley, Inc. · Apr 1986