Cleared Traditional

LIFEPORT POLYURETHANE CATHETER (K895871) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895871 · Strato Medical Corp. · General Hospital
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Nov 1989
Decision
44d
Days
Class 2
Risk

K895871 is an FDA 510(k) clearance for the LIFEPORT POLYURETHANE CATHETER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 44 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 Strato Medical Corp. devices

Submission Details

510(k) Number K895871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1989
Decision Date November 17, 1989
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 42
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K895871.
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AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
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MEDTRONIC CATHETER ACCESS PORT MODEL 8500
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HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987