Cleared Traditional

DOUBLE LUMEN SUBCLAVIAN CATHETER (K823135) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823135 · Abbott Laboratories · Gastroenterology & Urology device
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Mar 1983
Decision
130d
Days
Class 2
Risk

K823135 is an FDA 510(k) clearance for the DOUBLE LUMEN SUBCLAVIAN CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 130 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

Submission Details

510(k) Number K823135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1982
Decision Date March 07, 1983
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
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 17
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K823135.
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
RIGHT ATRIAL CATHETER
K822964 · Quinton, Inc. · Nov 1982
RIGHT ARTERIAL CATHETER
K822910 · Quinton, Inc. · Nov 1982
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA
K822134 · Shiley, Inc. · Aug 1982