The following data is part of a premarket notification filed by Varian Medical Systems Inc. with the FDA for Bravos Afterloader Family: Bravos Afterloader System, Transfer Guide Tubes And Length Assessment Device.
| Device ID | K221797 |
| 510k Number | K221797 |
| Device Name: | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes And Length Assessment Device |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Varian Medical Systems Inc. 3100 Hansen Way, M/S/E-110 Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems Inc. 3100 Hansen Way, M/S/E-110 Palo Alto, CA 94304 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389029200 | K221797 | 000 |
| 10816389020372 | K221797 | 000 |
| 20816389020362 | K221797 | 000 |
| 10816389020358 | K221797 | 000 |
| 00816389020344 | K221797 | 000 |
| 10816389020334 | K221797 | 000 |
| 10816389020327 | K221797 | 000 |
| 10816389020310 | K221797 | 000 |