The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Coredx™ Pulmonary Mini-forceps.
| Device ID | K183085 |
| 510k Number | K183085 |
| Device Name: | CoreDx™ Pulmonary Mini-Forceps |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Elena Nieves |
| Correspondent | Elena Nieves 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 | 2018-11-06 |
| Decision Date | 2019-03-08 |