Cleared Traditional

K860094 - HURWITZ DIALYSIS CATHETER

K860094 is an FDA 510(k) clearance for HURWITZ DIALYSIS CATHETER, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K860094 · Gish Biomedical, Inc. · Gastroenterology & Urology device
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Apr 1986
Decision
87d
Days
Class 2
Risk

K860094 is an FDA 510(k) clearance for the HURWITZ DIALYSIS CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 87 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K860094

510(k) Number K860094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1986
Decision Date April 07, 1986
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 K860094.
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
SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL
K852070 · Shiley, Inc. · Jun 1985
SINGLE LUMEN SUBCLAVIAN CANNULA
K840197 · Shiley, Inc. · Apr 1984
DUAL LUMEN SUBCLAVIAN CANNULA
K833848 · Shiley, Inc. · Dec 1983