The following data is part of a premarket notification filed by Vein360, Llc with the FDA for Vein360 Endovenous Radiofrequency Ablation (rfa) Catheter.
| Device ID | K191073 |
| 510k Number | K191073 |
| Device Name: | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Vein360, LLC 4460 Lake Forest Drive Blue Ash, OH 45242 -3741 |
| Contact | Suzanne Meyer |
| Correspondent | Suzanne Meyer Vein360, LLC 4460 Lake Forest Drive Blue Ash, OH 45242 -3741 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-22 |
| Decision Date | 2019-10-22 |
| Summary: | summary |