Cleared Traditional

K890029 - HEMO-CATH SILICONE DOUBLE LUMEN CATHETER

K890029 is an FDA 510(k) clearance for HEMO-CATH SILICONE DOUBLE LUMEN CATHETER, manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K890029 · Medical Components, Inc. · Gastroenterology & Urology device
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Apr 1989
Decision
103d
Days
Class 2
Risk

K890029 is an FDA 510(k) clearance for the HEMO-CATH SILICONE DOUBLE LUMEN CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 103 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K890029

510(k) Number K890029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1989
Decision Date April 17, 1989
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
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 K890029.
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
K891753 · Akcess Medical Products, Inc. · Jun 1989
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K
K891755 · Akcess Medical Products, Inc. · Jun 1989
SUBCLAVIAN HEMODIALYSIS CATHETER
K884322 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
MODIFIED VAS-CATH CATHETER REPAIR KIT
K890099 · Vas-Cath, Inc. · Apr 1989
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · Impra, Inc. · Dec 1988
VAS-CATH CATHETER REPAIR KIT
K883768 · Vas-Cath, Inc. · Nov 1988