The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Urethral Warming Catheter Kit.
| Device ID | K211149 |
| 510k Number | K211149 |
| Device Name: | Urethral Warming Catheter Kit |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Varian Medical Systems, Inc. 9825 Spectrum Drive, Building 2, Suite 250 Austin, TX 78717 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 9825 Spectrum Drive, Building 2, Suite 250 Austin, TX 78717 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2022-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810563020977 | K211149 | 000 |