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 |