The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Steerable Stylet.
| Device ID | K040001 |
| 510k Number | K040001 |
| Device Name: | STEERABLE STYLET |
| Classification | Stylet, Catheter |
| Applicant | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | James Jenkins |
| Correspondent | James Jenkins SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-02 |
| Decision Date | 2004-03-09 |
| Summary: | summary |