The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Mps 3 Myocardial Protection System.
| Device ID | K200438 |
| 510k Number | K200438 |
| Device Name: | MPS 3 Myocardial Protection System |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 |
| Contact | Tosan Onosode |
| Correspondent | Tosan Onosode 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 | 2020-02-24 |
| Decision Date | 2020-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624812219 | K200438 | 000 |
| 20634624531165 | K200438 | 000 |
| 20634624531073 | K200438 | 000 |
| 20634624531066 | K200438 | 000 |
| 20634624531059 | K200438 | 000 |
| 20634624531042 | K200438 | 000 |
| 20634624531028 | K200438 | 000 |
| 20634624516315 | K200438 | 000 |
| 20634624500369 | K200438 | 000 |
| 20634624500352 | K200438 | 000 |
| 20634624500345 | K200438 | 000 |
| 20634624500338 | K200438 | 000 |
| 20634624500321 | K200438 | 000 |
| 20634624500314 | K200438 | 000 |
| 20634624530168 | K200438 | 000 |
| 20634624530274 | K200438 | 000 |
| 20634624530397 | K200438 | 000 |
| 20634624700318 | K200438 | 000 |
| 20634624731022 | K200438 | 000 |
| 20634624533077 | K200438 | 000 |
| 20634624530328 | K200438 | 000 |
| 20634624530311 | K200438 | 000 |
| 20634624530304 | K200438 | 000 |
| 20634624530250 | K200438 | 000 |
| 20634624530236 | K200438 | 000 |
| 20634624530106 | K200438 | 000 |
| 20634624513123 | K200438 | 000 |
| 20634624513116 | K200438 | 000 |
| 20634624513109 | K200438 | 000 |
| 20634624513024 | K200438 | 000 |
| 20634624513017 | K200438 | 000 |
| 20634624513000 | K200438 | 000 |
| 20634624511853 | K200438 | 000 |
| 20634624511815 | K200438 | 000 |
| 20634624510085 | K200438 | 000 |
| 20634624530380 | K200438 | 000 |