The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Miar (minimally Invasive Aortic Root) Cannula With Flow-guard, Models 11012l And 11014l.
| Device ID | K100274 |
| 510k Number | K100274 |
| Device Name: | MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Caralee Walton |
| Correspondent | Caralee Walton MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-29 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994495499 | K100274 | 000 |
| 20613994495468 | K100274 | 000 |