The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tubing Pack.
Device ID | K171308 |
510k Number | K171308 |
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 | 2017-05-03 |
Decision Date | 2017-06-02 |
Summary: | summary |