Cleared Traditional

K884322 - SUBCLAVIAN HEMODIALYSIS CATHETER

K884322 is the FDA 510(k) clearance for SUBCLAVIAN HEMODIALYSIS CATHETER by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Gastroenterology & Urology device (product code LFJ) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K884322 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1989
Decision
193d
Days
Class 2
Risk

K884322 is an FDA 510(k) clearance for the SUBCLAVIAN HEMODIALYSIS CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 25, 1989 after a review of 193 days - an extended review 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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K884322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date April 25, 1989
Days to Decision 193 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
63d slower than avg
Panel avg: 130d · This submission: 193d
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 49
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K884322.
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K893439 · Medical Components, Inc. · Jun 1989
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
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
K890029 · Medical Components, Inc. · Apr 1989
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · Impra, Inc. · Dec 1988
MEDSURG ACUTE DIALYSIS TRAY
K880778 · Medsurg Industries, Inc. · Jul 1988