Cleared Traditional

K881493 - PORT-A-CATH IMPLANTABLE ACCESS SYSTEM -...

K881493 is the FDA 510(k) clearance for PORT-A-CATH IMPLANTABLE ACCESS SYSTEM -... by Pharmacia Deltec, Inc.. It is a Class 2 General Hospital device (product code LKG) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K881493 · Pharmacia Deltec, Inc. · General Hospital
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May 1988
Decision
42d
Days
Class 2
Risk

K881493 is an FDA 510(k) clearance for the PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.. Classified as Port & Catheter, Implanted, Subcutaneous, Intraventricular (product code LKG), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 20, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 882.5550 - 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 Pharmacia Deltec, Inc. devices

Submission Details

510(k) Number K881493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1988
Decision Date May 20, 1988
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular

Devices cleared under the same product code (LKG) and FDA review panel - the closest regulatory comparables to K881493.
CORDIS CSF RESERVOIR
K950315 · Cordis Corp. · May 1995
PORT-A-CATH PORTAL INTRODUCER FORCEPS
K881690 · Pharmacia Deltec, Inc. · May 1988
P-S MEDICAL VENTRICULAR ACCESS PORT
K874468 · Pudenz-Schulte Medical Research Corp. · Feb 1988
CSF-VENTRICULOSTOMY RESERVOIR
K874498 · Pudenz-Schulte Medical Research Corp. · Feb 1988
P-S MEDICAL CSF ACCESS DEV 15MM/25MM
K833822 · Pudenz-Schulte Medical Research Corp. · May 1984
HH SUBCUTANEOUS ACCESS PORT
K833672 · Holter-Hausner Intl. · Mar 1984