The following data is part of a premarket notification filed by Cambridge Interventional Llc with the FDA for Crf Radiofrequency Ablation System.
| Device ID | K192715 |
| 510k Number | K192715 |
| Device Name: | CRF Radiofrequency Ablation System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Cambridge Interventional LLC 78 Cambridge Street Burlington, MA 01803 |
| Contact | Michael A. Arnold |
| Correspondent | Michael A. Arnold Cambridge Interventional LLC 78 Cambridge Street Burlington, MA 01803 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-01-07 |