Cleared Special

AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE (K032962) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032962 · Arrow Intl., Inc. · General Hospital
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Oct 2003
Decision
36d
Days
Class 2
Risk

K032962 is an FDA 510(k) clearance for the AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on October 29, 2003 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arrow Intl., Inc. devices

Submission Details

510(k) Number K032962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date October 29, 2003
Days to Decision 36 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 128
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K032962.
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · Cook, Inc. · Feb 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500 · Becton, Dickinson & CO · Jan 2004
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
K033250 · Edwards Lifesciences, LLC · Dec 2003
SPECTRUM SILICONE CATHETER
K021557 · Cook, Inc. · May 2003
PEDIATRIC CENTRAL VENOUS CATHETER KIT
K023253 · B.Braun Medical, Inc. · May 2003
INTROCAN SAFETY IV CATHETER
K020785 · B.Braun Medical, Inc. · Aug 2002