Cleared Traditional

K951873 - STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM

K951873 is an FDA 510(k) clearance for STRATO/INFUSAIND MICROPORT VASCULAR ACC..., manufactured by Strato/Infusaid, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K951873 · Strato/Infusaid, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 1995
Decision
28d
Days
Class 2
Risk

K951873 is an FDA 510(k) clearance for the STRATO/INFUSAIND MICROPORT VASCULAR ACC. 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 May 19, 1995 after a review of 28 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/Infusaid, Inc. devices

FDA 510(k) Submission Details - K951873

510(k) Number K951873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date May 19, 1995
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 236
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