The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Stylet Kit, Models 6282, 6293, And 6254.
| Device ID | K010906 |
| 510k Number | K010906 |
| Device Name: | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 |
| 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 | 2001-03-26 |
| Decision Date | 2001-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994618720 | K010906 | 000 |
| 20613994618706 | K010906 | 000 |
| 20613994618683 | K010906 | 000 |
| 20613994618669 | K010906 | 000 |
| 20613994618645 | K010906 | 000 |
| 20613994618621 | K010906 | 000 |