Cleared Traditional

K853322 - MEDTRONIC ACCESS PORT MODEL 8500

K853322 is the FDA 510(k) clearance for MEDTRONIC ACCESS PORT MODEL 8500 by Medtronic Vascular. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K853322 · Medtronic Vascular · General Hospital
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Nov 1985
Decision
90d
Days
Class 2
Risk

K853322 is an FDA 510(k) clearance for the MEDTRONIC ACCESS PORT MODEL 8500. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 6, 1985 after a review of 90 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 Medtronic Vascular devices

Submission Details

510(k) Number K853322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date November 06, 1985
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 K853322.
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
IMPLANTOFIX
K851293 · Burron Medical Products, Inc. · Jan 1986
PORT-A-CATH
K832917 · Pharmacia, Inc. · Dec 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
K830730 · Pharmacia, Inc. · Jun 1983