The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Stylet Kit, Models 6254,6282,6293.
| Device ID | K003535 |
| 510k Number | K003535 |
| Device Name: | STYLET KIT, MODELS 6254,6282,6293 |
| Classification | Stylet, Catheter |
| Applicant | MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
| Contact | Karen Clement |
| Correspondent | Karen Clement MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2001-02-08 |