Cleared Traditional

K013182 - TRIPLE LUMEN CENTRAL VENOUS CATHETER

K013182 is the FDA 510(k) clearance for TRIPLE LUMEN CENTRAL VENOUS CATHETER by Cook, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K013182 · Cook, Inc. · General Hospital
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Jul 2002
Decision
280d
Days
Class 2
Risk

K013182 is an FDA 510(k) clearance for the TRIPLE LUMEN CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 280 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 Cook, Inc. devices

Submission Details

510(k) Number K013182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date July 01, 2002
Days to Decision 280 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
151d slower than avg
Panel avg: 129d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K013182.
PEDIATRIC CENTRAL VENOUS CATHETER KIT
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K030571 · Ethicon Endo-Surgery, Inc. · Mar 2003
INTROCAN SAFETY IV CATHETER
K020785 · B.Braun Medical, Inc. · Aug 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139 · Micro Therapeutics, Inc. · Apr 2002
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
K013800 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073 · Becton Dickinson Infusion Therapy Systems, Inc. · Nov 2001