Cleared Traditional

K864446 - PORT-A-CATH VASCULAR ACCESS SYSTEMS

K864446 is an FDA 510(k) clearance for PORT-A-CATH VASCULAR ACCESS SYSTEMS, manufactured by Pharmacia, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K864446 · Pharmacia, Inc. · General Hospital
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Mar 1987
Decision
139d
Days
Class 2
Risk

K864446 is an FDA 510(k) clearance for the PORT-A-CATH VASCULAR ACCESS SYSTEMS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 139 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 Pharmacia, Inc. devices

FDA 510(k) Submission Details - K864446

510(k) Number K864446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date March 31, 1987
Days to Decision 139 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 129d · This submission: 139d
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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K864446.
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
K870886 · Strato Medical Corp. · May 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · C.R. Bard, Inc. · Apr 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K870519 · Norfolk Medical Products, Inc. · Apr 1987
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
K864349 · C.R. Bard, Inc. · Feb 1987
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
K863750 · C.R. Bard, Inc. · Dec 1986
LIFE-PORT IMPLANTABLE VASCULAR ACCESS
K853827 · Strato Medical Corp. · Nov 1986