The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Rf Disc Catheter Electrode System.
| Device ID | K001741 |
| 510k Number | K001741 |
| Device Name: | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM |
| Classification | Arthroscope |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Kristine Canavan |
| Correspondent | Kristine Canavan RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-08 |
| Decision Date | 2000-10-23 |