LUNERAY; CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM— 510(k) K140803

Name: FDA 510(k) clearance K140803
Creator: U.S. Food and Drug Administration
Published: 2014-06-26

Substantially Equivalent

Nucletron B.V.

FDA 510(k) clearance K140803 for LUNERAY; CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM, Substantially Equivalent on 2014-06-26. Applicant: Nucletron B.V.. Device class: 2.

Clearance details

Device name as filed: LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
Applicant: Nucletron B.V.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2014-03-31
Decision date: 2014-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

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