Cleared Traditional

FLUORO CATHETER

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

About This 510(k) Submission

K953950 is an FDA 510(k) clearance for the FLUORO CATHETER, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on September 18, 1995, 27 days after receiving the submission on August 22, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K953950 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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