Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
FDA 510(k) K191073 · Vein 360, LLC
510(k) numberK191073
Submission
- Device name
- Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
- Applicant
- Vein 360, LLC
Blue Ash, OH, US - Received
- April 22, 2019
- Decision date
- October 22, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special | Stryker Sustainability Solutions | 03/28/2023SE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | Stryker Sustainability Solutions | 05/13/2022SE |
| K211203 | Green OR Reprocessed Aquamantys Bipolar SealerNUJ · Traditional | Green Or, LLC | 04/07/2022SE |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 10/31/2018SE |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/23/2018SE |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/20/2018SE |
| K173214 | NES Reprocessed RF Stylet (RFS)NUJ · Traditional | Northeast Scientific, Inc. (Nes) | 03/27/2018SE |
| K173740 | Reprocessed DePuy Mitek Ablation WandNUJ · Traditional | Renovo, Inc. | 03/19/2018SE |
| K173741 | Reprocessed ArthoCare Ablation WandNUJ · Traditional | Renovo, Inc. | 03/05/2018SE |
More from Renovo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…OWQ · Traditional | 10/24/2023SE |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterOWQ · Traditional | 08/25/2023SE |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterOWQ · Traditional | 06/06/2023SE |
Questions and answers
When was Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter cleared by the FDA?
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (K191073) received a 510(k) decision of Substantially Equivalent on October 22, 2019, 183 days after the submission was received.
What is the product code of K191073?
The FDA product code is NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4400.