The following data is part of a premarket notification filed by Salter Labs, Inc. with the FDA for Trach- Vac Endotracheal Tube (sftvpu) Subglottic Suction Tube With Salter Flex-tip And Salter Thincuff, Trach- Vac Endotracheal Tube (sftvvc) Subglottic Suction Tube With Salter Flex-tip And Salter Thincuff.
| Device ID | K190878 |
| 510k Number | K190878 |
| Device Name: | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Salter Labs, Inc. 2365 Camino Vida Roble Carlsbad, CA 92011 |
| Contact | Mara Caler |
| Correspondent | Paul Dryden Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-04 |
| Decision Date | 2020-01-10 |