The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest Mps Perfusion Assisted Direct Coronary Artery Bypass (padcab).
| Device ID | K994274 |
| 510k Number | K994274 |
| Device Name: | QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) |
| Classification | Pump, Infusion |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Malcolm Lewis |
| Correspondent | Malcolm Lewis QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | FRN |
| Subsequent Product Code | DRS |
| Subsequent Product Code | DTR |
| Subsequent Product Code | DWF |
| Subsequent Product Code | DXS |
| Subsequent Product Code | KRL |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-05-31 |
| Summary: | summary |