The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medtronic Bio-medicus Handcrank Model 150.
| Device ID | K926357 |
| 510k Number | K926357 |
| Device Name: | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Dena D Becker |
| Correspondent | Dena D Becker MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490409094 | K926357 | 000 |
| 00673978170626 | K926357 | 000 |
| 00673978169880 | K926357 | 000 |
| 00673978166858 | K926357 | 000 |
| 00673978166841 | K926357 | 000 |
| 00673978166834 | K926357 | 000 |