Cleared Traditional

K841149 - VASCULAR-ACCESS PORT - ENLARGEMENT

K841149 is the FDA 510(k) clearance for VASCULAR-ACCESS PORT - ENLARGEMENT by Norfolk Medical Products, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K841149 · Norfolk Medical Products, Inc. · General Hospital
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Apr 1984
Decision
109d
Days
Class 2
Risk

K841149 is an FDA 510(k) clearance for the VASCULAR-ACCESS PORT - ENLARGEMENT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Norfolk Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 109 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 Norfolk Medical Products, Inc. devices

Submission Details

510(k) Number K841149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date April 24, 1984
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
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 106
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K841149.
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
IMPLANTOFIX
K851293 · Burron Medical Products, Inc. · Jan 1986
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · Medtronic Vascular · Nov 1985
PORT-A-CATH
K832917 · Pharmacia, Inc. · Dec 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
K830730 · Pharmacia, Inc. · Jun 1983