The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Bio-medicus Pediatric Cannula And Introducers.
| Device ID | K143083 |
| 510k Number | K143083 |
| Device Name: | Bio-Medicus Pediatric Cannula And Introducers |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC, INC 8200 CORAL ST NE Mounds View, MN 55112 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund MEDTRONIC, INC 8200 CORAL ST NE Mounds View, MN 55112 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-27 |
| Decision Date | 2015-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169623163 | K143083 | 000 |
| 00763000116309 | K143083 | 000 |
| 00763000116316 | K143083 | 000 |
| 00763000116323 | K143083 | 000 |
| 00763000116330 | K143083 | 000 |
| 00763000116347 | K143083 | 000 |
| 00763000116354 | K143083 | 000 |
| 00763000116361 | K143083 | 000 |
| 00643169623095 | K143083 | 000 |
| 00643169623101 | K143083 | 000 |
| 00643169623118 | K143083 | 000 |
| 00643169623125 | K143083 | 000 |
| 00643169623132 | K143083 | 000 |
| 00643169623149 | K143083 | 000 |
| 00643169623156 | K143083 | 000 |
| 00763000116293 | K143083 | 000 |