Cleared Traditional

K984189 - ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER

K984189 is an FDA 510(k) clearance for ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER, manufactured by Maxxim Medical. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K984189 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
163d
Days
Class 2
Risk

K984189 is an FDA 510(k) clearance for the ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Maxxim Medical (Athens, US). The FDA issued a Cleared decision on May 5, 1999 after a review of 163 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Maxxim Medical devices

FDA 510(k) Submission Details - K984189

510(k) Number K984189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date May 05, 1999
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K984189.
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590 · Baxter Healthcare Corp · Oct 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · Cook, Inc. · Aug 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
K991406 · Terumo Medical Corp. · Jun 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1999
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
K984055 · Sims Deltec, Inc. · Jan 1999
INTROCAN SAFETY IV CATHETER
K982805 · B.Braun Medical, Inc. · Jan 1999