Cleared Traditional

K884322 - SUBCLAVIAN HEMODIALYSIS CATHETER

K884322 is an FDA 510(k) clearance for SUBCLAVIAN HEMODIALYSIS CATHETER, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Gastroenterology & Urology device with 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
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K884322

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
62d slower than avg
Panel avg: 131d · This submission: 193d
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 63
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
MODIFIED VAS-CATH CATHETER REPAIR KIT
K890099 · Vas-Cath, Inc. · Apr 1989
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · Impra, Inc. · Dec 1988