Cleared Traditional

K903220 - PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM

K903220 is an FDA 510(k) clearance for PORT-A-CATH IMPLANTABLE DRUG DELIVERY S..., manufactured by Pharmacia Deltec, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K903220 · Pharmacia Deltec, Inc. · General Hospital
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Oct 1990
Decision
79d
Days
Class 2
Risk

K903220 is an FDA 510(k) clearance for the PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 10, 1990 after a review of 79 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.

FDA 510(k) Submission Details - K903220

510(k) Number K903220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date October 10, 1990
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 287
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K903220.
GERARD MEDICAL, INC. TRIM-PORT
K903364 · Gerard Medical Enterprises, Inc. · Oct 1990
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K904077 · Med Institute, Inc. · Oct 1990
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
K903691 · Therex Corp. · Oct 1990
DUAL PORT
K901419 · Infusaid Corp. · Sep 1990
CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
K901722 · Device Labs, Inc. · Jul 1990
LIFE-LINE(TM) VASCULAR ACCESS SYSTEM
K895030 · Medical Engineering and Development Institute · Apr 1990
K903220 · PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
Download PDF Pharmacia Deltec, Inc.