Cleared Traditional

LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM

K140803 · Nucletron B.V. · Radiology

Jun 2014

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K140803 is an FDA 510(k) clearance for the LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on June 26, 2014, 87 days after receiving the submission on March 31, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K140803 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2014
Decision Date	June 26, 2014
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF