The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Slim Clip Applier.
| Device ID | K180914 |
| 510k Number | K180914 |
| Device Name: | Aesculap Slim Clip Applier |
| Classification | Applier, Aneurysm Clip |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Paul Amudala |
| Correspondent | Paul Amudala Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046955289684 | K180914 | 000 |
| 04046955289677 | K180914 | 000 |
| 04046955289660 | K180914 | 000 |
| 04046955289653 | K180914 | 000 |