The following data is part of a premarket notification filed by Medtronic Inc with the FDA for Bio-medicus Adult Cannulae And Introducer.
Device ID | K180453 |
510k Number | K180453 |
Device Name: | Bio-Medicus Adult Cannulae And Introducer |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | Medtronic Inc 8200 Coral Street NE Mounds View, MN 55112 |
Contact | Huda Yusuf |
Correspondent | Huda Yusuf Medtronic Inc 8200 Coral Street NE 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 | 2018-02-20 |
Decision Date | 2018-03-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00763000193522 | K180453 | 000 |
00763000060596 | K180453 | 000 |
00763000060602 | K180453 | 000 |
00763000060619 | K180453 | 000 |
00763000060626 | K180453 | 000 |
00763000060633 | K180453 | 000 |
00763000193492 | K180453 | 000 |
00763000193508 | K180453 | 000 |
00763000193515 | K180453 | 000 |
00763000060589 | K180453 | 000 |