Cleared Traditional

K954433 - VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM

K954433 is an FDA 510(k) clearance for VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM, manufactured by Gish Biomedical, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K954433 · Gish Biomedical, Inc. · General Hospital
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Nov 1995
Decision
51d
Days
Class 2
Risk

K954433 is an FDA 510(k) clearance for the VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on November 15, 1995 after a review of 51 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K954433

510(k) Number K954433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date November 15, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
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 166
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K954433.
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