The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Bio-medicus Cannula Insertion Kit.
| Device ID | K150567 |
| 510k Number | K150567 |
| Device Name: | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund Medtronic, Inc. 7611 Northland Drive 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 | 2015-03-06 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169279616 | K150567 | 000 |
| 20643169279630 | K150567 | 000 |
| 20643169279623 | K150567 | 000 |
| 20763000116006 | K150567 | 000 |
| 20763000115993 | K150567 | 000 |
| 20763000115986 | K150567 | 000 |