Cleared Traditional

K140169 - VITAL-PORT CT VASCULAR ACCESS SYSTEM

K140169 is the FDA 510(k) clearance for VITAL-PORT CT VASCULAR ACCESS SYSTEM by Cook Incorporated. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K140169 · Cook Incorporated · General Hospital
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May 2014
Decision
118d
Days
Class 2
Risk

K140169 is an FDA 510(k) clearance for the VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 21, 2014 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 Incorporated devices

Submission Details

510(k) Number K140169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2014
Decision Date May 21, 2014
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 61
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K140169.
BardPort®, SlimPort®, and X-Port® Implanted Ports
K153359 · C.R. Bard, Inc. · May 2016
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
K150514 · C.R. Bard, Inc. · Nov 2015
Vital-Port Vascular Access System Power Injectable Port
K150733 · Cook Incorporated · May 2015
POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · C.R. Bard, Inc. · Nov 2012
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017 · AngioDynamics, Inc. · Jun 2010