The following data is part of a premarket notification filed by Nuvera Medical, Inc. with the FDA for Nuvision Ice Catheter.
| Device ID | K201775 |
| 510k Number | K201775 |
| Device Name: | NuVision ICE Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | NuVera Medical, Inc. 140 Knowles Dr. Los Gatos, CA 95032 |
| Contact | Robert Nardelli |
| Correspondent | Robert Nardelli NuVera Medical, Inc. 140 Knowles Dr. Los Gatos, CA 95032 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2021-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005688111 | K201775 | 000 |
| 00860005688104 | K201775 | 000 |