The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Axial Clip Applier.
| Device ID | K984109 |
| 510k Number | K984109 |
| Device Name: | AESCULAP AXIAL CLIP APPLIER |
| Classification | Applier, Aneurysm Clip |
| Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Contact | Lia S Jones |
| Correspondent | Lia S Jones AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-17 |
| Decision Date | 1999-02-12 |
| Summary: | summary |