The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-medicus Life Support Catheter And Introducer.
| Device ID | K201057 |
| 510k Number | K201057 |
| Device Name: | Bio-Medicus Life Support Catheter And Introducer |
| Classification | Single Lumen Ecmo Cannula |
| Applicant | Medtronic Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 |
| Contact | Juli Rubin |
| Correspondent | Juli Rubin Medtronic Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 |
| Product Code | QHW |
| CFR Regulation Number | 870.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000615604 | K201057 | 000 |
| 00763000615451 | K201057 | 000 |
| 00763000615444 | K201057 | 000 |
| 00763000615437 | K201057 | 000 |
| 00763000615420 | K201057 | 000 |
| 00763000615413 | K201057 | 000 |
| 00763000615406 | K201057 | 000 |
| 00763000615390 | K201057 | 000 |
| 00763000615383 | K201057 | 000 |
| 00763000615376 | K201057 | 000 |
| 00763000615369 | K201057 | 000 |
| 00763000615352 | K201057 | 000 |
| 00763000615345 | K201057 | 000 |
| 00763000615468 | K201057 | 000 |
| 00763000615475 | K201057 | 000 |
| 00763000615598 | K201057 | 000 |
| 00763000615581 | K201057 | 000 |
| 00763000615574 | K201057 | 000 |
| 00763000615567 | K201057 | 000 |
| 00763000615550 | K201057 | 000 |
| 00763000615543 | K201057 | 000 |
| 00763000615536 | K201057 | 000 |
| 00763000615529 | K201057 | 000 |
| 00763000615512 | K201057 | 000 |
| 00763000615505 | K201057 | 000 |
| 00763000615499 | K201057 | 000 |
| 00763000615482 | K201057 | 000 |
| 00763000615338 | K201057 | 000 |