The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Eopa 3d Arterial Cannula.
Device ID | K150422 |
510k Number | K150422 |
Device Name: | EOPA 3D Arterial Cannula |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC, INC. 7611 Northland Dr. Minneapolis, MN 55428 |
Contact | Chelsea L Pioske |
Correspondent | Chelsea L Pioske MEDTRONIC, INC. 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 | 2015-02-19 |
Decision Date | 2015-03-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20763000135700 | K150422 | 000 |
20763000135694 | K150422 | 000 |
20763000135526 | K150422 | 000 |
20763000135502 | K150422 | 000 |
20643169486250 | K150422 | 000 |
20643169486243 | K150422 | 000 |
00763000946852 | K150422 | 000 |
00763000946845 | K150422 | 000 |