The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle.
| Device ID | K163248 |
| 510k Number | K163248 |
| Device Name: | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Yingying Gao |
| Correspondent | Yingying Gao Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-03-27 |
| Summary: | summary |