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 |