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 |