The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesulap Kopitnik Avm Microclips And Applier.
| Device ID | K024349 |
| 510k Number | K024349 |
| Device Name: | AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER |
| Classification | Clip, Aneurysm |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-30 |
| Decision Date | 2003-03-24 |
| Summary: | summary |