The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Valvulotome W/fixed Tip.
| Device ID | K894496 |
| 510k Number | K894496 |
| Device Name: | OLYMPUS VALVULOTOME W/FIXED TIP |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Rick Geoffrion |
| Correspondent | Rick Geoffrion OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-10-12 |