The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Mc2 Two-stage Venous Cannula, Oval Mc2 Two-stage Venous Cannula, Thin Wall Two-stage Venous Cannula, Mc2x Three-stage Ve.
Device ID | K140165 |
510k Number | K140165 |
Device Name: | MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Contact | Jacqueline A Hauge |
Correspondent | Jacqueline A Hauge 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 | 2014-01-22 |
Decision Date | 2014-05-20 |
Summary: | summary |