The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Placer Model 6232 Steerable Stylet.
| Device ID | K000955 |
| 510k Number | K000955 |
| Device Name: | PLACER MODEL 6232 STEERABLE STYLET |
| Classification | Stylet, Catheter |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Contact | Mike Johnson |
| Correspondent | Mike Johnson MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-06-16 |