The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Tubing And Connectors With Trillium Biopassive Surface.
| Device ID | K012538 |
| 510k Number | K012538 |
| Device Name: | TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Marie Holm |
| Correspondent | Marie Holm MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2001-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20721902350089 | K012538 | 000 |