The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd with the FDA for Rescue Pulmonary Grasping Forceps.
| Device ID | K202987 |
| 510k Number | K202987 |
| Device Name: | Rescue Pulmonary Grasping Forceps |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Anrei Medical (Hangzhou) Co., Ltd No. 3 Ave 8, HEDA Hangzhou, CN 310018 |
| Contact | Huibing Yang |
| Correspondent | Jia Huang 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 | 2020-09-30 |
| Decision Date | 2021-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26948318968828 | K202987 | 000 |
| 16948318903921 | K202987 | 000 |