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 | K151895 |
510k Number | K151895 |
Device Name: | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
Classification | Biopsy Needle |
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 | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-10 |
Decision Date | 2015-10-22 |
Summary: | summary |