The following data is part of a premarket notification filed by Aesculap Inc. with the FDA for Aesculap Pas-port Proximal Anastomosis System.
| Device ID | K202124 |
| 510k Number | K202124 |
| Device Name: | Aesculap PAS-Port Proximal Anastomosis System |
| Classification | Clip, Implantable |
| Applicant | Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Sierra Mertz |
| Correspondent | Sierra Mertz Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2020-09-02 |