Cleared Traditional

K140169 - VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM

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

K140169 · Cook Incorporated · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K140169

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.

LJT Device Classification - Class 2, Special Controls

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 254
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K140169.
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
INVISIPORT
K141146 · Stealth Therapeutics, Incorporated · May 2015
POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014
MEDCOMP GEN III POWER INJECTABLE PORT
K132177 · Medcomp ( Medical Components) · Dec 2013
POLYSITE IMPLANTABLE INFUSION PORTS
K122834 · Perouse Medical · Dec 2013
K140169 · VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
Download PDF FDA Summary Cook Incorporated