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 | K181903 |
| 510k Number | K181903 |
| 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 Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 3100 Hansen Way 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 | 2018-07-16 |
| Decision Date | 2018-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389027947 | K181903 | 000 |
| 00816389027466 | K181903 | 000 |
| 00816389027473 | K181903 | 000 |
| 00816389027480 | K181903 | 000 |
| 00816389027497 | K181903 | 000 |
| 00816389027503 | K181903 | 000 |
| 00816389027510 | K181903 | 000 |
| 00816389027527 | K181903 | 000 |
| 00816389027534 | K181903 | 000 |
| 00816389027541 | K181903 | 000 |
| 00816389027558 | K181903 | 000 |
| 00816389027565 | K181903 | 000 |
| 00816389027572 | K181903 | 000 |
| 00816389027589 | K181903 | 000 |
| 00816389027596 | K181903 | 000 |
| 00816389027602 | K181903 | 000 |
| 00816389027930 | K181903 | 000 |