The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Octopus Te Stabilizer & Accessories.
| Device ID | K041338 |
| 510k Number | K041338 |
| Device Name: | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES |
| Classification | Stabilizer, Heart |
| Applicant | MEDTRONIC VASCULAR 7601 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Scott Cundy |
| Correspondent | Scott Cundy MEDTRONIC VASCULAR 7601 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | MWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-19 |
| Summary: | summary |