Cleared Traditional

K864349 - MEDIPORT II SINGLE LUM/PORT IMPLANT VAS...

K864349 is the FDA 510(k) clearance for MEDIPORT II SINGLE LUM/PORT IMPLANT VAS... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

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 109
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K864349.
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
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
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986