The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Hycult Diamond Coronary Bypass Knife.
| Device ID | K900379 |
| 510k Number | K900379 |
| Device Name: | HYCULT DIAMOND CORONARY BYPASS KNIFE |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Contact | William F Jackson |
| Correspondent | William F Jackson ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-26 |
| Decision Date | 1990-03-19 |