The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Mps2 Myocardial Protection System Console.
| Device ID | K173716 |
| 510k Number | K173716 |
| Device Name: | MPS2 Myocardial Protection System Console |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 -4211 |
| Contact | Jan Hodges |
| Correspondent | Ronald S Warren Experien Group 224 Airport Parkway San Jose, CA 95110 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-05 |
| Decision Date | 2018-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624561148 | K173716 | 000 |
| 20634624516117 | K173716 | 000 |