The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Yasargil Titanium Aneurysm Clips (ftxxxt).
| Device ID | K970050 |
| 510k Number | K970050 |
| Device Name: | YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) |
| Classification | Clip, Aneurysm |
| Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Contact | Victoria Mmackinnon |
| Correspondent | Victoria Mmackinnon AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-11-26 |
| Summary: | summary |