Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
FDA 510(k) K140803 · Nucletron B.V.
510(k) numberK140803
Submission
- Device name
- Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
- Applicant
- Nucletron B.V.
Veenendaal, NL - Received
- March 31, 2014
- Decision date
- June 26, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | 07/24/2026SE |
| K251037 | Rectal ApplicatorJAQ · Traditional | 12/19/2025SE |
| K213942 | EsteyaJAD · Traditional | 01/11/2022SE |
| K201272 | GenevaJAQ · Traditional | 07/16/2020SE |
| K161688 | Advanced Gynecological ApplicatorJAQ · Traditional | 01/27/2017SE |
| K151272 | Henschke Titanium Applicator SetJAQ · Traditional | 06/23/2015SE |
| K142439 | Martinez Prostate Template SetJAQ · Traditional | 03/10/2015SE |
| K132816 | Oncentra BrachyMUJ · Traditional | 06/13/2014SE |
| K132889 | Fletcher Ct/Mr Shielded Applicator Set (6 MM) Fletcher Ct/Mr Shielded Applicator Set (4…JAQ · Traditional | 02/26/2014SE |
| K132874 | Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure Set 5F…JAQ · Special | 02/21/2014SE |
Questions and answers
When was Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM cleared by the FDA?
Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM (K140803) received a 510(k) decision of Substantially Equivalent on June 26, 2014, 87 days after the submission was received.
What is the product code of K140803?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.