The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Dlp Single Stage Venous Cannula Inflatable Cuff.
| Device ID | K120987 |
| 510k Number | K120987 |
| Device Name: | DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Emily Blus |
| Correspondent | Emily Blus MEDTRONIC INC. 7611 NORTHLAND DRIVE 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 | 2012-04-02 |
| Decision Date | 2012-06-06 |
| Summary: | summary |