The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap T-bar Aneurysm Clips (titanium & Phynox).
| Device ID | K043041 |
| 510k Number | K043041 |
| Device Name: | AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2004-12-09 |
| Summary: | summary |