Cleared Traditional

K873735 - MEDTRONIC CATHETER ACCESS PORT MODEL 8500

K873735 is an FDA 510(k) clearance for MEDTRONIC CATHETER ACCESS PORT MODEL 8500, manufactured by Medtronic Vascular. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K873735 · Medtronic Vascular · General Hospital
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Nov 1987
Decision
49d
Days
Class 2
Risk

K873735 is an FDA 510(k) clearance for the MEDTRONIC CATHETER 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 3, 1987 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K873735

510(k) Number K873735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date November 03, 1987
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 K873735.
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276 · Pharmacia Deltec, Inc. · Apr 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214 · Therex Corp. · Feb 1988
CHEMO-PORT
K874184 · Hdc Corp. · Dec 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)
K872838 · Norfolk Medical Products, Inc. · Aug 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987