Cleared Traditional

STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM (K953529) - FDA 510(k) Clearance

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

K953529 · Strato/Infusaid, Inc. · General Hospital
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Jan 1996
Decision
183d
Days
Class 2
Risk

K953529 is an FDA 510(k) clearance for the STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato/Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 183 days - an extended review 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: 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 Strato/Infusaid, Inc. devices

Submission Details

510(k) Number K953529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date January 26, 1996
Days to Decision 183 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 129d · This submission: 183d
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 47
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K953529.
CELSITE PORT WITH PRECONNECTED CATHETER
K962230 · B.Braun Medical, Inc. · Dec 1996
CELSITE PEDIATRIC VENOUS SYSTEM
K952435 · B.Braun Medical, Inc. · Apr 1996
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996
CELSITE VENOUS ACCESS SYSTEM OTW
K954297 · B.Braun Medical, Inc. · Dec 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748 · United States Surgical, A Division of Tyco Healthc · Aug 1995
CELSITE VENOUS SYSTEM
K952548 · B.Braun Medical, Inc. · Jul 1995