The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest Mps Back-up Sysyem.
| Device ID | K002366 |
| 510k Number | K002366 |
| Device Name: | QUEST MPS BACK-UP SYSYEM |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Doug Bryan |
| Correspondent | Doug Bryan QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | DWF |
| Subsequent Product Code | DRS |
| Subsequent Product Code | DTR |
| Subsequent Product Code | DXS |
| Subsequent Product Code | KRL |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-27 |
| Decision Date | 2000-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624510283 | K002366 | 000 |
| 20634624510214 | K002366 | 000 |
| 20634624510177 | K002366 | 000 |
| 20634624510153 | K002366 | 000 |