Cleared Traditional

NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007

K032372 · Nucletron Corporation · Radiology
Aug 2003
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K032372 is an FDA 510(k) clearance for the NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on August 15, 2003, 14 days after receiving the submission on August 1, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K032372 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2003
Decision Date August 15, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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