The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Mps 3 Nd Myocardial Protection System.
| Device ID | K201984 |
| 510k Number | K201984 |
| Device Name: | MPS 3 ND Myocardial Protection System |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 |
| Contact | Tosan Eweka |
| Correspondent | Tosan Eweka Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-17 |
| Decision Date | 2020-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624531004 | K201984 | 000 |
| 20634624530335 | K201984 | 000 |
| 20634624530373 | K201984 | 000 |
| 20634624530366 | K201984 | 000 |
| 20634624530359 | K201984 | 000 |
| 20634624530342 | K201984 | 000 |