The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tubing Pack.
| Device ID | K171979 |
| 510k Number | K171979 |
| Device Name: | Tubing Pack |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE (MVS83) Mounds View, MN 55112 |
| Contact | Renee Cveykus |
| Correspondent | Renee Cveykus Medtronic, Inc. 8200 Coral Sea Street NE (MVS83) Mounds View, MN 55112 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-10-27 |
| Summary: | summary |