The following data is part of a premarket notification filed by Nevap, Inc. with the FDA for Nevap Aspire Subglottic Suction Endotracheal Tube (asset) With Preloaded Stylet.
| Device ID | K172208 |
| 510k Number | K172208 |
| Device Name: | NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) With Preloaded Stylet |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | NeVap, Inc. 975 Dionne Way San Jose, CA 95133 |
| Contact | Brenton Hanlon |
| Correspondent | Janet Kwiatkowski MAE Consulting Group, LLC 119 North Road Deerfield, NH 03037 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2018-02-16 |
| Summary: | summary |