Cleared Traditional

K953950 - FLUORO CATHETER

K953950 is the FDA 510(k) clearance for FLUORO CATHETER by Cmt Medical Technologies, Ltd.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K953950 · Cmt Medical Technologies, Ltd. · Radiology device
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Sep 1995
Decision
27d
Days
Class 2
Risk

K953950 is an FDA 510(k) clearance for the FLUORO CATHETER. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on September 18, 1995 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight 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 Cmt Medical Technologies, Ltd. devices

Submission Details

510(k) Number K953950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date September 18, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 133
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