Cleared Traditional

K150514 - Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters

K150514 is an FDA 510(k) clearance for Power-Injectable Implantable Ports with..., manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K150514 · C.R. Bard, Inc. · General Hospital
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Nov 2015
Decision
266d
Days
Class 2
Risk

K150514 is an FDA 510(k) clearance for the Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 266 days - an extended review cycle.

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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K150514

510(k) Number K150514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2015
Decision Date November 20, 2015
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 198
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K150514.
NMI DUAL PORT II
K151239 · Navilyst Medical, Inc. · Jun 2016
BardPort®, SlimPort®, and X-Port® Implanted Ports
K153359 · C.R. Bard, Inc. · May 2016
NMI Port, NMI Port II
K153228 · Navilyst Medical, Inc. · Dec 2015
Vital-Port Vascular Access System Power Injectable Port
K150733 · Cook Incorporated · May 2015
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
K140169 · Cook Incorporated · May 2014
POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014