Cleared Special

LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS

K091598 · Nucletron Corp. · Radiology
Jun 2009
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K091598 is an FDA 510(k) clearance for the LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on June 29, 2009, 26 days after receiving the submission on June 3, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K091598 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2009
Decision Date June 29, 2009
Days to Decision 26 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

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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