The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest Heart Insulation Pad.
| Device ID | K925049 |
| 510k Number | K925049 |
| Device Name: | QUEST HEART INSULATION PAD |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | QUEST MEDICAL, INC. 4103 BILLY MITCHELL DR. Dallas, TX 75244 |
| Contact | Drew Johnson |
| Correspondent | Drew Johnson QUEST MEDICAL, INC. 4103 BILLY MITCHELL DR. Dallas, TX 75244 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-06 |
| Decision Date | 1994-02-01 |