The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Cuff Inflator (vci).
| Device ID | K173914 |
| 510k Number | K173914 |
| Device Name: | VORTRAN Cuff Inflator (VCI) |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | VORTRAN Medical Technology 1, Inc. 21 Goldenland Court #100 Sacramento, CA 95834 |
| Contact | James Lee |
| Correspondent | James Lee VORTRAN Medical Technology 1, Inc. 21 Goldenland Court #100 Sacramento, CA 95834 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-05-25 |
| Summary: | summary |