Cleared Traditional

K864349 - MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT

K864349 is an FDA 510(k) clearance for MEDIPORT II SINGLE LUM/PORT IMPLANT VAS..., 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 98-day FDA review.

K864349 · C.R. Bard, Inc. · General Hospital
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Feb 1987
Decision
98d
Days
Class 2
Risk

K864349 is an FDA 510(k) clearance for the MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 98 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K864349

510(k) Number K864349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date February 10, 1987
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 K864349.
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · C.R. Bard, Inc. · Apr 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K870519 · Norfolk Medical Products, Inc. · Apr 1987
PORT-A-CATH VASCULAR ACCESS SYSTEMS
K864446 · Pharmacia, Inc. · Mar 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
NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT
K863723 · Norfolk Medical Products, Inc. · Oct 1986